510(k) K032770
K032770 is an FDA 510(k) premarket notification submitted by Coapt Systems, Inc. for the device "ENDOTINE FOREHEAD DEVICE". The FDA issued a decision of Substantially Equivalent on October 8, 2003. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Coapt Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2003
- Date Received
- September 8, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type