INSTANT COLDGEL

Pack, Hot Or Cold, Disposable

PRISM TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Prism Technologies, Inc. with the FDA for Instant Coldgel.

Pre-market Notification Details

Device IDK953541
510k NumberK953541
Device Name:INSTANT COLDGEL
ClassificationPack, Hot Or Cold, Disposable
Applicant PRISM TECHNOLOGIES, INC. 555 THIRTEENTH STREET, N.W. Washington,  DC  20004
ContactHoward M Holstein
CorrespondentHoward M Holstein
PRISM TECHNOLOGIES, INC. 555 THIRTEENTH STREET, N.W. Washington,  DC  20004
Product CodeIMD  
CFR Regulation Number890.5710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-28
Decision Date1995-10-05

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