NEZHAT-DORSEY(TM) REUSABLE ASPIRATION-VAC(TM) PROBES WITH AND WITHOUT PUNCTURE CANNULA

Laparoscope, General & Plastic Surgery

AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by American Hydro-surgical Instruments, Inc. with the FDA for Nezhat-dorsey(tm) Reusable Aspiration-vac(tm) Probes With And Without Puncture Cannula.

Pre-market Notification Details

• Device ID: K946089
• 510k Number: K946089
• Device Name: NEZHAT-DORSEY(TM) REUSABLE ASPIRATION-VAC(TM) PROBES WITH AND WITHOUT PUNCTURE CANNULA
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. 430 COMMERCE DR. Delray Beach, FL 33445
• Contact: Martine D Schneider
• Correspondent: Martine D Schneider; AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. 430 COMMERCE DR. Delray Beach, FL 33445
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-12-13
• Decision Date: 1995-03-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00801741077128	K946089	000