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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 K964436
Device Name WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM
Applicant
WESTERN SURGICAL INSTRUMENT CO.
11202 FOREST RAIN
SAN ANTONIO,  TX  78233
Applicant Contact PHIL WOLF
Correspondent
WESTERN SURGICAL INSTRUMENT CO.
11202 FOREST RAIN
SAN ANTONIO,  TX  78233
Correspondent Contact PHIL WOLF
Regulation Number884.1720
Classification Product Code
HET  
Date Received11/05/1996
Decision Date 01/30/1997
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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