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FDA 510(k), K010675, ENSIL FABRIC
FDA 510(k), K010675, ENSIL FABRIC
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510(K) Number: K010675
Device Name: ENSIL FABRIC
Manufacturer: GOTTFRIED MEDICAL, INC.
Device Classification Name: Elastomer, Silicone, For Scar Management
Regulation Number: 878.4025
Classification Product Code: MDA
Date Received: 03/06/2001
Decision Date: 05/30/2001
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ENSIL FABRIC
Manufacturer: GOTTFRIED MEDICAL, INC.
Device Classification Name: Elastomer, Silicone, For Scar Management
Regulation Number: 878.4025
Classification Product Code: MDA
Date Received: 03/06/2001
Decision Date: 05/30/2001
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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