PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE

Set, Administration, Intravascular

PHARMACIA DELTEC, INC.

The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Pharmacia Deltec Extension Set With Anti-siphon Valve.

Pre-market Notification Details

Device IDK942046
510k NumberK942046
Device Name:PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE
ClassificationSet, Administration, Intravascular
Applicant PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul,  MN  55112
ContactDavid H Short
CorrespondentDavid H Short
PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul,  MN  55112
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-28
Decision Date1994-10-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
35019517184208 K942046 000

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