GEBAUER'S CHLORIDE FINE NOZZE

Refrigerant, Topical (vapocoolant)

GEBAUER CO.

The following data is part of a premarket notification filed by Gebauer Co. with the FDA for Gebauer's Chloride Fine Nozze.

Pre-market Notification Details

Device IDK991514
510k NumberK991514
Device Name:GEBAUER'S CHLORIDE FINE NOZZE
ClassificationRefrigerant, Topical (vapocoolant)
Applicant GEBAUER CO. 9410 ST. CATHERINE AVE. Cleveland,  OH  44104
ContactDenise E Spellman
CorrespondentDenise E Spellman
GEBAUER CO. 9410 ST. CATHERINE AVE. Cleveland,  OH  44104
Product CodeMLY  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-30
Decision Date1999-07-16
Summary:summary

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