510(k) K950499
K950499 is an FDA 510(k) premarket notification submitted by American Hydro-Surgical Instruments, Inc. for the device "NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on June 16, 1995. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. American Hydro-Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 1995
- Date Received
- February 6, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.4160
- Review Panel
- OB
- Submission Type