WAVICIDE MONITOR STRIPS

Sterilant, Medical Devices

SERIM RESEARCH CORP.

The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Wavicide Monitor Strips.

Pre-market Notification Details

Device IDK932047
510k NumberK932047
Device Name:WAVICIDE MONITOR STRIPS
ClassificationSterilant, Medical Devices
Applicant SERIM RESEARCH CORP. P.O. BOX 4002 Elkhart,  IN  46514 -0002
ContactMichael Mckenna
CorrespondentMichael Mckenna
SERIM RESEARCH CORP. P.O. BOX 4002 Elkhart,  IN  46514 -0002
Product CodeMED  
CFR Regulation Number880.6885 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-27
Decision Date1994-06-02

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