510(k) K963420
K963420 is an FDA 510(k) premarket notification submitted by Orthopaedic Biosystems, Ltd. for the device "CANCELLOUS SCREW WASHER". The FDA issued a decision of Substantially Equivalent on November 15, 1996. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Orthopaedic Biosystems, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 1996
- Date Received
- August 30, 1996
- 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