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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 K875097
Device Name DISPOSABLE SYRINGE
Applicant
California Ent.
P.O. Box 878
Sun Valley,  CA  91353
Applicant Contact CHARLIE B SUH
Correspondent
California Ent.
P.O. Box 878
Sun Valley,  CA  91353
Correspondent Contact CHARLIE B SUH
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/10/1987
Decision Date 02/16/1988
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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