All 510(k) summaries shall contain the following information: (1) The submitters name, address, telephone number, a contact person, and the date the summary was prepared; (2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the...
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and Zip Code;however,the street address may be omitted if it is shown in a current city directory or telephone directory.The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section.In the case of non...
Food and Drug Administration, HHS Pt. 807 device. Records required to be main- tained under paragraph (b) of this sec- tion must be transferred to the new manufacturer or importer of the device and maintained for the required period of time. [62 FR 27191, May 19, 1997, as amended at...
and Zip Code;however,the street address may be omitted if it is shown in a current city directory or telephone directory.The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section.In the case of non...
801.1Medicaldevices;nameandplaceofbusinessofmanufacturer,packeror<br>distributor.<br>医疗器械,制造商、包装商或分销商的经营名称和地址<br>(a)Thelabelofadeviceinpackageformshallspecif..
【单选题】() School bullying will never stop if we do not address the that bullying is just a normal rite of passage- some inevitable part of growing u【单选题】() No matter how much love confessions she has made, the poor boy remains to her.【单选题】() It is said that choosing ...
Thanks for the update, though while you addressed my first and fourth bullets, you didn't address my second and third, which may help in resolving things. (BTW, you write "charly_arehart". I'm just curious: did that really appear to you anywhere in your view of this thr...
801.1 Medical devices; name and place of business of manufacturer, packer or distributor. 医疗器械,制造商、包装商或分销商的经营名称和地址 (a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. 器械包装的...
The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (8) Inactive ingredient means any component other than an ``active ingredient. ...