510(k) K130431
K130431 is an FDA 510(k) premarket notification submitted by Dallen Medical, Inc. for the device "COMPRESSYN BAND". The FDA issued a decision of Substantially Equivalent on Jul 25, 2013. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Dallen Medical, Inc. has 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 25, 2013
- Date Received
- Feb 21, 2013
- 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
- 510(k)