30 ML OR 60 ML PEDI-SYRINGE FILTER

Set, Blood Transfusion

BLOOD PRODUCTS SPECIALTIES LLC

The following data is part of a premarket notification filed by Blood Products Specialties Llc with the FDA for 30 Ml Or 60 Ml Pedi-syringe Filter.

Pre-market Notification Details

Device IDK050805
510k NumberK050805
Device Name:30 ML OR 60 ML PEDI-SYRINGE FILTER
ClassificationSet, Blood Transfusion
Applicant BLOOD PRODUCTS SPECIALTIES LLC 184 SEIFFERT COURT Oceanside,  NY  11572
ContactAlan A Waldman
CorrespondentAlan A Waldman
BLOOD PRODUCTS SPECIALTIES LLC 184 SEIFFERT COURT Oceanside,  NY  11572
Product CodeBRZ  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-30
Decision Date2005-06-20
Summary:summary

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