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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 K952553
Device Name ALPHA MEDICA DISPOSABLE, STERILE, NONPYROGENIC SYRINGE
Applicant
Alpha Medica
136 SE Front St.
P.O. Box 953
Mullins,  SC  29574
Applicant Contact MAKRAM A BISHARA
Correspondent
Alpha Medica
136 SE Front St.
P.O. Box 953
Mullins,  SC  29574
Correspondent Contact MAKRAM A BISHARA
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/01/1995
Decision Date 10/03/1995
Decision Substantially Equivalent (SESE)
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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