BOWIE-DICK MINI PAK, MODEL BD 115

Indicator, Physical/chemical Sterilization Process

STERITEC PRODUCTS, INC.

The following data is part of a premarket notification filed by Steritec Products, Inc. with the FDA for Bowie-dick Mini Pak, Model Bd 115.

Pre-market Notification Details

Device IDK024293
510k NumberK024293
Device Name:BOWIE-DICK MINI PAK, MODEL BD 115
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant STERITEC PRODUCTS, INC. 599 TOPEKA WAY, SUITE 700 Castle Rock,  CO  80109
ContactLinda Nelson
CorrespondentLinda Nelson
STERITEC PRODUCTS, INC. 599 TOPEKA WAY, SUITE 700 Castle Rock,  CO  80109
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-24
Decision Date2003-08-11

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