STERRAD CHEMICAL INDICATOR

Indicator, Physical/chemical Sterilization Process

JOHNSON & JOHNSON MEDICAL, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Sterrad Chemical Indicator.

Pre-market Notification Details

Device IDK921910
510k NumberK921910
Device Name:STERRAD CHEMICAL INDICATOR
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington,  TX  76004 -3130
ContactWendt
CorrespondentWendt
JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington,  TX  76004 -3130
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-23
Decision Date1993-10-04

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