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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 K123710
Device Name UNITOX BOTOX SYRINGE
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  
Subsequent Product Code
FMI  
Date Received12/04/2012
Decision Date 05/09/2013
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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