Prolene Polypropylene Mesh Plug W/ Onlay Patch
FDA 510(k) K915774 · ETHICON, Inc.
510(k) numberK915774
Submission
- Device name
- Prolene Polypropylene Mesh Plug W/ Onlay Patch
- Applicant
- ETHICON, Inc.
Somerville, NJ, US - Received
- December 24, 1991
- Decision date
- March 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Prolene Polypropylene Mesh Plug W/ Onlay Patch cleared by the FDA?
Prolene Polypropylene Mesh Plug W/ Onlay Patch (K915774) received a 510(k) decision of Substantially Equivalent on March 2, 1992, 69 days after the submission was received.
What is the product code of K915774?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.