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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 K955412
Device Name A.S.D. SAFETY TROCAR
Applicant
AMERICAN SURGICAL DEVICES
41917 OSGOOD RD.
FREMONT,  CA  94539
Applicant Contact HENRYK PTT
Correspondent
AMERICAN SURGICAL DEVICES
41917 OSGOOD RD.
FREMONT,  CA  94539
Correspondent Contact HENRYK PTT
Regulation Number884.1720
Classification Product Code
HET  
Date Received11/27/1995
Decision Date 05/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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