CLASSIX CHEMICAL STERILIZATION INDICATOR

Indicator, Physical/chemical Sterilization Process

PROPPER MFG. CO., INC.

The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Classix Chemical Sterilization Indicator.

Pre-market Notification Details

Device IDK102894
510k NumberK102894
Device Name:CLASSIX CHEMICAL STERILIZATION INDICATOR
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant PROPPER MFG. CO., INC. 36-04 SKILLMAN AVE. Long Island City,  NY  11101
ContactAndrew Sharavara
CorrespondentAndrew Sharavara
PROPPER MFG. CO., INC. 36-04 SKILLMAN AVE. Long Island City,  NY  11101
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-30
Decision Date2011-05-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30818087011823 K102894 000

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