BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR

Indicator, Biological 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 Bi-o.k. Self-contained Biological Indicator.

Pre-market Notification Details

Device IDK991618
510k NumberK991618
Device Name:BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR
ClassificationIndicator, Biological 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 CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-11
Decision Date2001-01-24
Summary:summary

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