510(k) K896589
K896589 is an FDA 510(k) premarket notification submitted by Optik for the device "MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP". The FDA issued a decision of Substantially Equivalent on December 27, 1989. The device falls under product code LRZ (Screwdriver, Surgical), a Class I device regulated under 21 CFR 878.4800. Optik has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 1989
- Date Received
- November 21, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screwdriver, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type