FDA 510(k), K142061, SILHOUETTE INSTALIFT

FDA 510(k), K142061, SILHOUETTE INSTALIFT

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510(K) Number: K142061
Device Name: SILHOUETTE INSTALIFT
Manufacturer: SILHOUETTE LIFT, INC.
Device Classification Name: suture, absorbable, synthetic, polyglycolic acid
Regulation Number: 878.4493
Classification Product Code: GAM
Date Received: 07/30/2014
Decision Date: 04/24/2015
Regulation Medical Specialty: General & Plastic Surgery

Total pages: 1,778
Fully redacted pages: 1,568
Content pages: 210

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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