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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
510(k) Number K950499
Device Name NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS
Applicant
American Hydro-Surgical Instruments, Inc.
430 Commerce Dr.
Delray Beach,  FL  33445
Applicant Contact MARTINE D SCHNEIDER
Correspondent
American Hydro-Surgical Instruments, Inc.
430 Commerce Dr.
Delray Beach,  FL  33445
Correspondent Contact MARTINE D SCHNEIDER
Regulation Number884.4160
Classification Product Code
KNF  
Subsequent Product Code
KGD  
Date Received02/06/1995
Decision Date 06/16/1995
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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