3&4 WAY PLASTIC STOPCOCKS, NONSTERILE

Stopcock, I.v. Set

TRONOMED, INC.

The following data is part of a premarket notification filed by Tronomed, Inc. with the FDA for 3&4 Way Plastic Stopcocks, Nonsterile.

Pre-market Notification Details

Device IDK792125
510k NumberK792125
Device Name:3&4 WAY PLASTIC STOPCOCKS, NONSTERILE
ClassificationStopcock, I.v. Set
Applicant TRONOMED, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
ContactAndrew Harautuneian
CorrespondentAndrew Harautuneian
TRONOMED, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFMG  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-10-24
Decision Date1980-01-16

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