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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K946380
Device Name NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)
Applicant
American Hydro-Surgical Instruments, Inc.
430 Commerce Dr.
Delray Beach,  FL  33445
Applicant Contact MARTINE SCHNEIDER
Correspondent
American Hydro-Surgical Instruments, Inc.
430 Commerce Dr.
Delray Beach,  FL  33445
Correspondent Contact MARTINE SCHNEIDER
Regulation Number884.1720
Classification Product Code
HET  
Date Received12/13/1994
Decision Date 07/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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