510(k) K141264
K141264 is an FDA 510(k) premarket notification submitted by Dallen Medical, Inc. for the device "TENSYN BAND, TENSYN FRACTURE PLATES". The FDA issued a decision of Substantially Equivalent on Aug 21, 2014. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Dallen Medical, Inc. has 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 21, 2014
- Date Received
- May 15, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Washer, Bolt Nut
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)