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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mini Endoscope, Gastroenterology-Urology
510(k) Number K933106
Device Name ENDOSCOPE
Applicant
Origin Medsystems, Inc.
135 Constitution Dr.
Menlo Park,  CA  94025
Applicant Contact JILL SCHWEIGER
Correspondent
Origin Medsystems, Inc.
135 Constitution Dr.
Menlo Park,  CA  94025
Correspondent Contact JILL SCHWEIGER
Regulation Number876.1500
Classification Product Code
ODF  
Date Received06/25/1993
Decision Date 10/19/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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