Dexon 'S' Polyglycolic Acid Mesh
FDA 510(k) K830889 · Davis & Geck, Inc.
510(k) numberK830889
Submission
- Device name
- Dexon 'S' Polyglycolic Acid Mesh
- Applicant
- Davis & Geck, Inc.
Walker, MI, US - Received
- March 21, 1983
- Decision date
- May 9, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was Dexon 'S' Polyglycolic Acid Mesh cleared by the FDA?
Dexon 'S' Polyglycolic Acid Mesh (K830889) received a 510(k) decision of Substantially Equivalent on May 9, 1983, 49 days after the submission was received.
What is the product code of K830889?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.