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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 K896118
Device Name NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE
Applicant
AMERICAN SURGICAL INSTRUMENTS CORP.
2550 M STREET, N.W.
WASHINGTON,  DC  20037
Applicant Contact STUART M PAPE
Correspondent
AMERICAN SURGICAL INSTRUMENTS CORP.
2550 M STREET, N.W.
WASHINGTON,  DC  20037
Correspondent Contact STUART M PAPE
Regulation Number884.1720
Classification Product Code
HET  
Date Received10/23/1989
Decision Date 03/28/1990
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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