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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light source, fiberoptic, routine
510(k) Number K123359
Device Name OVS1 VIDEO SYSTEM
Applicant
OLIVE MEDICAL CORP.
2302 Presidents Dr Ste D
Salt Lake City,  UT  84120
Applicant Contact BRIAN DEAN
Correspondent
OLIVE MEDICAL CORP.
2302 Presidents Dr Ste D
Salt Lake City,  UT  84120
Correspondent Contact BRIAN DEAN
Regulation Number876.1500
Classification Product Code
FCW  
Subsequent Product Code
GCJ  
Date Received10/31/2012
Decision Date 12/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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