STERITITE PROCESS INDICATOR ACCESSORIES

Indicator, Physical/chemical Sterilization Process

CASE MEDICAL, INC.

The following data is part of a premarket notification filed by Case Medical, Inc. with the FDA for Steritite Process Indicator Accessories.

Pre-market Notification Details

Device IDK982151
510k NumberK982151
Device Name:STERITITE PROCESS INDICATOR ACCESSORIES
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant CASE MEDICAL, INC. 65 RAILROAD AVE. Ridgefield,  NJ  07657 -0402
ContactMarcia Frieze
CorrespondentTania Lupu
CASE MEDICAL, INC. 65 RAILROAD AVE. Ridgefield,  NJ  07657 -0402
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-18
Decision Date1999-02-09

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