Peri-Strips Dry - Staple Line Reinforcement
FDA 510(k) K971048 · Bio-Vascular, Inc.
510(k) numberK971048
Submission
- Device name
- Peri-Strips Dry - Staple Line Reinforcement
- Applicant
- Bio-Vascular, Inc.
St. Paul, MN, US - Received
- March 21, 1997
- Decision date
- May 9, 1997
- 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 Peri-Strips Dry - Staple Line Reinforcement cleared by the FDA?
Peri-Strips Dry - Staple Line Reinforcement (K971048) received a 510(k) decision of Substantially Equivalent on May 9, 1997, 49 days after the submission was received.
What is the product code of K971048?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.