510(k) K843368
K843368 is an FDA 510(k) premarket notification submitted by Kapp Surgical Instrument, Inc. for the device "KAPP SPINAL BUTTON". The FDA issued a decision of Substantially Equivalent on September 12, 1984. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Kapp Surgical Instrument, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1984
- Date Received
- August 28, 1984
- 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