Puritan OptiTranz Liquid Stuart Collection And Transport System

Culture Media, Non-propagating Transport

PURITAN MEDICAL PRODUCTS LLC

The following data is part of a premarket notification filed by Puritan Medical Products Llc with the FDA for Puritan Optitranz Liquid Stuart Collection And Transport System.

Pre-market Notification Details

Device IDK142366
510k NumberK142366
Device Name:Puritan OptiTranz Liquid Stuart Collection And Transport System
ClassificationCulture Media, Non-propagating Transport
Applicant PURITAN MEDICAL PRODUCTS LLC 31 SCHOOL STREET P.O. BOX 149 Guilford,  ME  04443
ContactMehdi Karamchi
CorrespondentMehdi Karamchi
PURITAN MEDICAL PRODUCTS LLC 31 SCHOOL STREET P.O. BOX 149 Guilford,  ME  04443
Product CodeJSM  
Subsequent Product CodeJTW
Subsequent Product CodeLIO
CFR Regulation Number866.2390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-25
Decision Date2015-01-09
Summary:summary

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