510(k) K946380
NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V) by
American Hydro-Surgical Instruments, Inc.
— Product Code HET
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 1995
- Date Received
- December 13, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laparoscope, Gynecologic (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1720
- Review Panel
- OB
- Submission Type