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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Instrument
510(k) Number K930686
Device Name MIDMARK SURGICAL LIGHTING SYSTEMS
Applicant
Midmark Corp.
60 Vista Dr.
P.O. Box 286
Versailles,  OH  45380
Applicant Contact BRADLEY SEIDEN
Correspondent
Midmark Corp.
60 Vista Dr.
P.O. Box 286
Versailles,  OH  45380
Correspondent Contact BRADLEY SEIDEN
Regulation Number878.4580
Classification Product Code
FSQ  
Subsequent Product Code
FSY  
Date Received02/10/1993
Decision Date 07/30/1993
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
Predetermined Change
Control Plan Authorized		 No
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