PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)

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 Propper Vapor Line Pcd (steam Sterilization Process Challenge Test).

Pre-market Notification Details

Device IDK031152
510k NumberK031152
Device Name:PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant PROPPER MFG. CO., INC. 36-04 SKILLMAN AVE. Long Island City,  NY  11101
ContactJohn D Dyckman
CorrespondentJohn D Dyckman
PROPPER MFG. CO., INC. 36-04 SKILLMAN AVE. Long Island City,  NY  11101
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-11
Decision Date2004-08-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30818087010994 K031152 000

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