Bard Pelvisoft Acellular Collagen Biomesh
FDA 510(k) K031332 · C.R. Bard, Inc.
510(k) numberK031332
Submission
- Device name
- Bard Pelvisoft Acellular Collagen Biomesh
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- April 28, 2003
- Decision date
- May 15, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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 Bard Pelvisoft Acellular Collagen Biomesh cleared by the FDA?
Bard Pelvisoft Acellular Collagen Biomesh (K031332) received a 510(k) decision of Substantially Equivalent on May 15, 2003, 17 days after the submission was received.
What is the product code of K031332?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.