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FDA 510(k), K963004, BIONECT CREAM
FDA 510(k), K963004, BIONECT CREAM
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510(K) Number: K963004
Device Name: BIONECT CREAM
Manufacturer: FIDIA PHARMACEUTICAL CORP.
Device Classification Name: dressing, wound and burn, hydrogel w/drug and/or biologic
Regulation Number:
Classification Product Code: MGQ
Date Received: 08/02/1996
Decision Date: 02/12/1997
Regulation Medical Specialty:
Device Name: BIONECT CREAM
Manufacturer: FIDIA PHARMACEUTICAL CORP.
Device Classification Name: dressing, wound and burn, hydrogel w/drug and/or biologic
Regulation Number:
Classification Product Code: MGQ
Date Received: 08/02/1996
Decision Date: 02/12/1997
Regulation Medical Specialty:
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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