LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE

Set, Administration, Intravascular

STRATO MEDICAL CORP.

The following data is part of a premarket notification filed by Strato Medical Corp. with the FDA for Lifeport(r) 7 Inch Continuous Infusion W/y-site.

Pre-market Notification Details

Device IDK870582
510k NumberK870582
Device Name:LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE
ClassificationSet, Administration, Intravascular
Applicant STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly,  MA  01915
ContactFenton, Jr.
CorrespondentFenton, Jr.
STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly,  MA  01915
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-11
Decision Date1987-04-23

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