STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW

Set, I.v. Fluid Transfer

VALUMED

The following data is part of a premarket notification filed by Valumed with the FDA for Steri-spouts; Bag-spout, Vial-spout, Transfer Mixer; Rapidflow, Vialflow, Transflow.

Pre-market Notification Details

Device IDK023539
510k NumberK023539
Device Name:STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW
ClassificationSet, I.v. Fluid Transfer
Applicant VALUMED 1439 LIVE OAK ST. SUITE A Niceville,  FL  32578
ContactThomas E Cottone
CorrespondentThomas E Cottone
VALUMED 1439 LIVE OAK ST. SUITE A Niceville,  FL  32578
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-22
Decision Date2002-12-17
Summary:summary

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