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510(k) Documentation – CanGaroo RM Antibacterial Envelope (K233991, Elutia, Inc.)
510(k) Documentation – CanGaroo RM Antibacterial Envelope (K233991, Elutia, Inc.)
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510(K) Number: K233991
Device Name: CanGaroo RM Antibacterial Envelope
Manufacturer: Elutia Inc.
Device Classification Name: Mesh, Surgical
Regulation Number: 878.3300
Classification Product Code: FTM
Date Received: 12/18/2023
Decision Date: 06/14/2024
Regulation Medical Specialty: General & Plastic Surgery
Request Contents: All 510(k) documentation and pre-submission communications for Elutia, Inc. "CanGaroo RM Antibacterial Envelope" (K233991).
Device Name: CanGaroo RM Antibacterial Envelope
Manufacturer: Elutia Inc.
Device Classification Name: Mesh, Surgical
Regulation Number: 878.3300
Classification Product Code: FTM
Date Received: 12/18/2023
Decision Date: 06/14/2024
Regulation Medical Specialty: General & Plastic Surgery
Request Contents: All 510(k) documentation and pre-submission communications for Elutia, Inc. "CanGaroo RM Antibacterial Envelope" (K233991).
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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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