510(k) K880309
K880309 is an FDA 510(k) premarket notification submitted by Winn Hirsch & Assoc. for the device "TYPE 316L STAINLESS STEEL WIRE". The FDA issued a decision of Substantially Equivalent on February 29, 1988. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Winn Hirsch & Assoc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 29, 1988
- Date Received
- January 25, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cerclage, Fixation
- Device Class
- Class II
- Regulation Number
- 888.3010
- Review Panel
- OR
- Submission Type