510(k) K961122
K961122 is an FDA 510(k) premarket notification submitted by Stryker Instruments for the device "STRYKER KNIFELIGHT". The FDA issued a decision of Substantially Equivalent on August 22, 1996. The device falls under product code FTD (Lamp, Surgical), a Class II device regulated under 21 CFR 878.4580. Stryker Instruments has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 1996
- Date Received
- March 21, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type