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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, Accessories
510(k) Number K901154
Device Name MICROTEK'S SURGICAL LAMP HANDLE & COVER
Applicant
Microbio-Medics, Inc.
P.O. Box 1147
Tucker,  GA  30085
Applicant Contact A SMALLWOOD
Correspondent
Microbio-Medics, Inc.
P.O. Box 1147
Tucker,  GA  30085
Correspondent Contact A SMALLWOOD
Regulation Number878.4580
Classification Product Code
FTA  
Date Received03/13/1990
Decision Date 03/20/1990
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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