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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 COURT
OCEANSIDE,  NY  11572
Applicant Contact ALAN A WALDMAN
Correspondent
BLOOD PRODUCTS SPECIALTIES LLC
184 SEIFFERT COURT
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
Recalls CDRH Recalls
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