Steam-Dot Process Indicator

Indicator, Physical/chemical Sterilization Process

Propper Manufacturing Co., Inc.

The following data is part of a premarket notification filed by Propper Manufacturing Co., Inc. with the FDA for Steam-dot Process Indicator.

Pre-market Notification Details

Device IDK210553
510k NumberK210553
Device Name:Steam-Dot Process Indicator
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant Propper Manufacturing Co., Inc. 36-04 Skillman Avenue Long Island City,  NY  11101
ContactAndrew Sharavara
CorrespondentAndrew Sharavara
Propper Manufacturing Co., Inc. 36-04 Skillman Avenue Long Island City,  NY  11101
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-25
Decision Date2021-05-19

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