CMS IV EXTENSION SETS

Tubing, Fluid Delivery

CHURCHILL MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Churchill Medical Systems, Inc. with the FDA for Cms Iv Extension Sets.

Pre-market Notification Details

Device IDK884370
510k NumberK884370
Device Name:CMS IV EXTENSION SETS
ClassificationTubing, Fluid Delivery
Applicant CHURCHILL MEDICAL SYSTEMS, INC. 905 SHEEHY DR. Horsham,  PA  19044
ContactJoel Marcus
CorrespondentJoel Marcus
CHURCHILL MEDICAL SYSTEMS, INC. 905 SHEEHY DR. Horsham,  PA  19044
Product CodeFPK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-18
Decision Date1988-11-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30849884002592 K884370 000
30849884000451 K884370 000
30849884000444 K884370 000
30849884000376 K884370 000
30849884000314 K884370 000
30849884000260 K884370 000
30849884000567 K884370 000
30849884000550 K884370 000
30849884000321 K884370 000
30849884004008 K884370 000
30849884003957 K884370 000
30849884004442 K884370 000
30849884002585 K884370 000
30849884002769 K884370 000
30849884002660 K884370 000
30849884000468 K884370 000
30849884000536 K884370 000
30849884001465 K884370 000
30849884002554 K884370 000
30849884001939 K884370 000
30849884001724 K884370 000
30849884001601 K884370 000
30849884001571 K884370 000
30849884001250 K884370 000
30849884003018 K884370 000
30849884002745 K884370 000
30849884002714 K884370 000
30849884002677 K884370 000
30849884002646 K884370 000
30849884002639 K884370 000
30849884002035 K884370 000
30849884001588 K884370 000
30849884005142 K884370 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.