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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 K965121
Device Name CANNULA
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 Received12/23/1996
Decision Date 03/20/1997
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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