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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Device, Medical Examination, Ac Powered
510(k) Number K931197
Device Name MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT
Applicant
Meddev International Corp.
P.O. Box 1352
Los Altos,  CA  94023
Applicant Contact JOHN M BLACKMORE
Correspondent
Meddev International Corp.
P.O. Box 1352
Los Altos,  CA  94023
Correspondent Contact JOHN M BLACKMORE
Regulation Number880.6320
Classification Product Code
KZF  
Date Received03/09/1993
Decision Date 09/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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