510(k) K935357
K935357 is an FDA 510(k) premarket notification submitted by Surgiquip, Inc. for the device "SNAP RECIPROCATING SAW". The FDA issued a decision of Substantially Equivalent on January 28, 1994. The device falls under product code GAF (Spatula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Surgiquip, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1994
- Date Received
- November 4, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spatula, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type