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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Single Patient Use, Portable, Nonpowered
510(k) Number K910167
Device Name MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM
Applicant
Microbio-Medics, Inc.
P.O. Box 1147
Tucker,  GA  30085
Applicant Contact GREGORY A SMALLWOOD
Correspondent
Microbio-Medics, Inc.
P.O. Box 1147
Tucker,  GA  30085
Correspondent Contact GREGORY A SMALLWOOD
Regulation Number878.4680
Classification Product Code
GCY  
Date Received01/15/1991
Decision Date 04/15/1991
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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