STERI-DENT, STERI-SURE

Wrap, Sterilization

CPAC, INC.

The following data is part of a premarket notification filed by Cpac, Inc. with the FDA for Steri-dent, Steri-sure.

Pre-market Notification Details

Device IDK110867
510k NumberK110867
Device Name:STERI-DENT, STERI-SURE
ClassificationWrap, Sterilization
Applicant CPAC, INC. 2364 LEICESTER RD. P.O. BOX 175 Leicester,  NY  14481 -0175
ContactJeffrey S Crane
CorrespondentJeffrey S Crane
CPAC, INC. 2364 LEICESTER RD. P.O. BOX 175 Leicester,  NY  14481 -0175
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-29
Decision Date2011-07-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B234FRGSSNP400651 K110867 000
B234FRGSSNP400639 K110867 000
B234FRGSSNP400638 K110867 000
B234FRGSSNP400637 K110867 000
B234FRGSSNP400636 K110867 000

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