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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 K915116
Device Name TROCAR SHEATH ANCHOR
Applicant
Origin Medsystems, Inc.
1021 Howard Ave.
San Carlos,  CA  94070
Applicant Contact RICHARD RUSH
Correspondent
Origin Medsystems, Inc.
1021 Howard Ave.
San Carlos,  CA  94070
Correspondent Contact RICHARD RUSH
Regulation Number884.1720
Classification Product Code
HET  
Date Received11/13/1991
Decision Date 06/12/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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