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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name saw, pneumatically powered
510(k) Number K893949
Device Name #157 EXAM LIGHT
Applicant
MEDMARK, INC.
versailles,  OH  45380
Applicant Contact john oldiges
Correspondent
MEDMARK, INC.
versailles,  OH  45380
Correspondent Contact john oldiges
Regulation Number878.4820
Classification Product Code
KFK  
Date Received06/01/1989
Decision Date 08/07/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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