510(k) K030256
K030256 is an FDA 510(k) premarket notification submitted by Kinamed, Inc. for the device "ISO-ELASTIC CERCLAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 21, 2003. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Kinamed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2003
- Date Received
- January 24, 2003
- 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