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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K952421
Device Name NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS
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 Number876.1500
Classification Product Code
GCJ  
Date Received05/23/1995
Decision Date 06/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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