ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID

Fixative, Acid Containing

ALPHA-TEC SYSTEMS, INC.

The following data is part of a premarket notification filed by Alpha-tec Systems, Inc. with the FDA for Ats Schaudinn's Fixative W/acetic Acid.

Pre-market Notification Details

Device IDK883062
510k NumberK883062
Device Name:ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID
ClassificationFixative, Acid Containing
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 CodeLDW  
CFR Regulation Number864.4010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-19
Decision Date1988-08-04

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