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FDA 510(k), K023594, TENO FIX
FDA 510(k), K023594, TENO FIX
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510(K) Number: K023594
Device Name: TENO FIX
Manufacturer: ORTHEON MEDICAL, LLC.
Device Classification Name: suture, nonabsorbable, steel, monofilament and multifilament, sterile
Regulation Number: 878.4495
Classification Product Code: GAQ
Date Received: 10/25/2002
Decision Date: 05/15/2003
Regulation Medical Specialty: General & Plastic Surgery
Device Name: TENO FIX
Manufacturer: ORTHEON MEDICAL, LLC.
Device Classification Name: suture, nonabsorbable, steel, monofilament and multifilament, sterile
Regulation Number: 878.4495
Classification Product Code: GAQ
Date Received: 10/25/2002
Decision Date: 05/15/2003
Regulation Medical Specialty: General & Plastic Surgery
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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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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