STERI-DENT, STERI-SURE

Sterilizer, Dry Heat

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 IDK094026
510k NumberK094026
Device Name:STERI-DENT, STERI-SURE
ClassificationSterilizer, Dry Heat
Applicant CPAC, INC. 2364 LEICESTER RD. P.O. BOX 175 Leicester,  NY  14481 -0175
ContactJeffrey Crane
CorrespondentJeffrey Crane
CPAC, INC. 2364 LEICESTER RD. P.O. BOX 175 Leicester,  NY  14481 -0175
Product CodeKMH  
CFR Regulation Number880.6870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-30
Decision Date2011-07-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B234KMHSD301000230 K094026 000
B234KMHSD301000115 K094026 000
B234KMHSD201000230 K094026 000
B234KMHSD201000115 K094026 000

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