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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K932361
Device Name BASIC SKIN PREP TRAY
Applicant
Mcbar Industries
13 Greene St.
Beverly,  MA  01915
Applicant Contact CARL BARSANTI
Correspondent
Mcbar Industries
13 Greene St.
Beverly,  MA  01915
Correspondent Contact CARL BARSANTI
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
KDD  
Date Received03/10/1993
Decision Date 12/13/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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