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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K120278
Device Name WIRELESS IMAGE TRANSMITTER UNIT
Applicant
Olympus Medical Systems Corp.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Applicant Contact SHERI MUSGNUNG
Correspondent
Olympus Medical Systems Corp.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Correspondent Contact SHERI MUSGNUNG
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/30/2012
Decision Date 08/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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