510(k) K992537
K992537 is an FDA 510(k) premarket notification submitted by Bio-Vascular, Inc. for the device "PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED". The FDA issued a decision of Substantially Equivalent on February 22, 2000. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Bio-Vascular, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2000
- Date Received
- July 29, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type