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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 K960936
Device Name RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]
Applicant
ORIGIN MEDSYSTEMS, INC.
135 CONSTITUTION DR.
MENLO PARK,  CA  94025
Applicant Contact ANTHONY DURSO
Correspondent
ORIGIN MEDSYSTEMS, INC.
135 CONSTITUTION DR.
MENLO PARK,  CA  94025
Correspondent Contact ANTHONY DURSO
Regulation Number884.1720
Classification Product Code
HET  
Date Received03/08/1996
Decision Date 07/24/1996
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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