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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 K081547
Device Name BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC
Applicant
Bio-Med USA, Inc.
111 Ellison St.
Paterson,  NJ  07505
Applicant Contact YOUNG CHI
Correspondent
Bio-Med USA, Inc.
111 Ellison St.
Paterson,  NJ  07505
Correspondent Contact YOUNG CHI
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/02/2008
Decision Date 09/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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