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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 K921716
Device Name DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM
Applicant
AMERICAN SURGICAL INSTRUMENTS CORP.
430 COMMERCE DRIVE, SUITE 50E
DELRAY BEACH,  FL  33445
Applicant Contact DORSEY, III
Correspondent
AMERICAN SURGICAL INSTRUMENTS CORP.
430 COMMERCE DRIVE, SUITE 50E
DELRAY BEACH,  FL  33445
Correspondent Contact DORSEY, III
Regulation Number884.1720
Classification Product Code
HET  
Date Received04/09/1992
Decision Date 11/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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