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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, incandescent, diagnostic
510(k) Number K960081
Device Name BATTERY POWERED ENDOSCCOPIC LIGHT SOURCE
Applicant
MITSUBISHI CABLE AMERICA, INC.
10551 WULFF DR.
ORANGE,  CA  92667
Applicant Contact RONALD J EHMSEN
Correspondent
MITSUBISHI CABLE AMERICA, INC.
10551 WULFF DR.
ORANGE,  CA  92667
Correspondent Contact RONALD J EHMSEN
Regulation Number876.1500
Classification Product Code
FCQ  
Date Received01/11/1996
Decision Date 03/12/1996
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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