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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 K962777
Device Name AMR MINI-LAPAROSCOPE
Applicant
Applied Medical Resources
26051 Merit Cir.
Bldg. 104
Launa Hills,  CA  92653
Applicant Contact HOWARD V ROWE
Correspondent
Applied Medical Resources
26051 Merit Cir.
Bldg. 104
Launa Hills,  CA  92653
Correspondent Contact HOWARD V ROWE
Regulation Number884.1720
Classification Product Code
HET  
Date Received07/17/1996
Decision Date 08/06/1997
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
Predetermined Change
Control Plan Authorized		 No
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