ATS PARA-SET IODINE ALCOHOL SOLUTION

Stains, Microbiologic

ALPHA-TEC SYSTEMS, INC.

The following data is part of a premarket notification filed by Alpha-tec Systems, Inc. with the FDA for Ats Para-set Iodine Alcohol Solution.

Pre-market Notification Details

Device IDK883049
510k NumberK883049
Device Name:ATS PARA-SET IODINE ALCOHOL SOLUTION
ClassificationStains, Microbiologic
Applicant ALPHA-TEC SYSTEMS, INC. 18271 MCDURMOTT WEST, STE I Irvine,  CA  92714
ContactLaurie A Williams
CorrespondentLaurie A Williams
ALPHA-TEC SYSTEMS, INC. 18271 MCDURMOTT WEST, STE I Irvine,  CA  92714
Product CodeJTS  
CFR Regulation Number864.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-19
Decision Date1988-08-17

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