STOPCOCKS

Stopcock, I.v. Set

TRANSAMERICA DELAVAL, INC.

The following data is part of a premarket notification filed by Transamerica Delaval, Inc. with the FDA for Stopcocks.

Pre-market Notification Details

Device IDK851986
510k NumberK851986
Device Name:STOPCOCKS
ClassificationStopcock, I.v. Set
Applicant TRANSAMERICA DELAVAL, INC. 325 HALSTEAD ST. P.O. BIN 7087 Pasadena,  CA  91109
ContactRichard G Ekstrom
CorrespondentRichard G Ekstrom
TRANSAMERICA DELAVAL, INC. 325 HALSTEAD ST. P.O. BIN 7087 Pasadena,  CA  91109
Product CodeFMG  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-07
Decision Date1985-05-23

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