INTRAVIA CONTAINER, EMPTY

Container, I.v.

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Intravia Container, Empty.

Pre-market Notification Details

Device IDK964853
510k NumberK964853
Device Name:INTRAVIA CONTAINER, EMPTY
ClassificationContainer, I.v.
Applicant BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake,  IL  60073
ContactMary E Snyder
CorrespondentMary E Snyder
BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake,  IL  60073
Product CodeKPE  
CFR Regulation Number880.5025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-03
Decision Date1997-03-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20085412035264 K964853 000
20085412029577 K964853 000
20085412029560 K964853 000
50085412003509 K964853 000
50085412003462 K964853 000
20085412003195 K964853 000
20085412000040 K964853 000

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