510(k) K140358
K140358 is an FDA 510(k) premarket notification submitted by Dallen Medical, Inc. for the device "COMPRESSYN STAPLE". The FDA issued a decision of Substantially Equivalent on Jun 2, 2014. The device falls under product code JDR (Staple, Fixation, Bone), 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
- Jun 2, 2014
- Date Received
- Feb 12, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)