510(k) K954483
K954483 is an FDA 510(k) premarket notification submitted by Stryker Instruments for the device "STRYKER SAGITTAL SAW ATTACHMENT". The FDA issued a decision of Substantially Equivalent on January 30, 1996. The device falls under product code GFA (Blade, Saw, General & Plastic Surgery, Surgical), a Class I device regulated under 21 CFR 878.4820. Stryker Instruments has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1996
- Date Received
- September 27, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blade, Saw, General & Plastic Surgery, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type