WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA

Set, Administration, Intravascular

CHURCHILL MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Churchill Medical Systems, Inc. with the FDA for Wing Safe Infusion Set 20 Ga, Shs2000 Series; Wing Safe Infusion Set 19 Ga, Shs1900 Series; Wing Safe Infusion Set 22 Ga.

Pre-market Notification Details

Device IDK020544
510k NumberK020544
Device Name:WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA
ClassificationSet, Administration, Intravascular
Applicant CHURCHILL MEDICAL SYSTEMS, INC. 87 VENTURE DR. Dover,  NH  03820
ContactKeith Paluch
CorrespondentKeith Paluch
CHURCHILL MEDICAL SYSTEMS, INC. 87 VENTURE DR. Dover,  NH  03820
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-15
Decision Date2002-03-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
38498840010540 K020544 000
38498840007199 K020544 000
38498840007182 K020544 000
38498840007175 K020544 000
58498840007162 K020544 000
38498840006604 K020544 000
30849884004145 K020544 000
38498840010731 K020544 000
38498840010380 K020544 000
38498840010373 K020544 000
58498840007209 K020544 000
38498840007212 K020544 000
58498840007223 K020544 000
38498840010533 K020544 000
38498840010526 K020544 000
38498840010519 K020544 000
58498840008770 K020544 000
58498840007292 K020544 000
38498840007281 K020544 000
58498840007261 K020544 000
38498840007250 K020544 000
58498840007247 K020544 000
38498840010267 K020544 000

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