INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)

Stopcock, I.v. Set

ELCAM MEDICAL ACAL

The following data is part of a premarket notification filed by Elcam Medical Acal with the FDA for Induction And Sampling Manifold (or Stopcock).

Pre-market Notification Details

Device IDK032393
510k NumberK032393
Device Name:INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
ClassificationStopcock, I.v. Set
Applicant ELCAM MEDICAL ACAL 7600 NORTH 15TH STREET SUITE 217 Phoenix,  AZ  85020
ContactBruce Ward
CorrespondentBruce Ward
ELCAM MEDICAL ACAL 7600 NORTH 15TH STREET SUITE 217 Phoenix,  AZ  85020
Product CodeFMG  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-04
Decision Date2003-09-12
Summary:summary

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