THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS

Syringe, Piston

THERMOGENESIS CORP.

The following data is part of a premarket notification filed by Thermogenesis Corp. with the FDA for Thermogenesis Drop Applicator, Kits, Spray Kits And Tips.

Pre-market Notification Details

Device IDK955282
510k NumberK955282
Device Name:THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS
ClassificationSyringe, Piston
Applicant THERMOGENESIS CORP. 11431 SUNRISE GOLD CIRCLE SUITE A Rancho Cordova,  CA  95742
ContactPhilip Coelho
CorrespondentPhilip Coelho
THERMOGENESIS CORP. 11431 SUNRISE GOLD CIRCLE SUITE A Rancho Cordova,  CA  95742
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-16
Decision Date1996-05-06
Summary:summary

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