FDA 510(k), K982577, NEUFINISH RESURFACING CREAM

FDA 510(k), K982577, NEUFINISH RESURFACING CREAM

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510(K) Number: K982577
Device Name: NEUFINISH RESURFACING CREAM
Manufacturer: NEUTROGENA CORP.
Device Classification Name: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Regulation Number:
Classification Product Code: MGQ
Date Received: 07/24/1998
Decision Date: 10/21/1998

Total pages: 276
Fully redacted pages: 176
Content pages: 100

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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