DELTA THERM COLD THERAPY SYSTEM

Pack, Hot Or Cold, Water Circulating

DELTATHERM

The following data is part of a premarket notification filed by Deltatherm with the FDA for Delta Therm Cold Therapy System.

Pre-market Notification Details

Device IDK945399
510k NumberK945399
Device Name:DELTA THERM COLD THERAPY SYSTEM
ClassificationPack, Hot Or Cold, Water Circulating
Applicant DELTATHERM 7038 RIVER RD. Pittsburgh,  PA  15225
ContactKirk A Dobbs
CorrespondentKirk A Dobbs
DELTATHERM 7038 RIVER RD. Pittsburgh,  PA  15225
Product CodeILO  
CFR Regulation Number890.5720 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-04
Decision Date1995-03-07

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