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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Blood Transfusion
510(k) Number K050805
Device Name 30 ML OR 60 ML PEDI-SYRINGE FILTER
Applicant
Blood Products Specialties, LLC
184 Seiffert Ct.
Oceanside,  NY  11572
Applicant Contact ALAN A WALDMAN
Correspondent
Blood Products Specialties, LLC
184 Seiffert Ct.
Oceanside,  NY  11572
Correspondent Contact ALAN A WALDMAN
Regulation Number880.5440
Classification Product Code
BRZ  
Subsequent Product Code
FMF  
Date Received03/30/2005
Decision Date 06/20/2005
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
Recalls CDRH Recalls
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