PISTON SYRINGE

Syringe, Piston

BAXA CORP.

The following data is part of a premarket notification filed by Baxa Corp. with the FDA for Piston Syringe.

Pre-market Notification Details

Device IDK951871
510k NumberK951871
Device Name:PISTON SYRINGE
ClassificationSyringe, Piston
Applicant BAXA CORP. 13760 EAST ARAPAHOE RD. Englewood,  CO  80112 -3903
ContactWilliam E Mckay
CorrespondentWilliam E Mckay
BAXA CORP. 13760 EAST ARAPAHOE RD. Englewood,  CO  80112 -3903
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-21
Decision Date1995-06-21

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