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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Water Circulating
510(k) Number K945399
Device Name DELTA THERM COLD THERAPY SYSTEM
Applicant
Deltatherm
7038 River Rd.
Pittsburgh,  PA  15225
Applicant Contact KIRK A DOBBS
Correspondent
Deltatherm
7038 River Rd.
Pittsburgh,  PA  15225
Correspondent Contact KIRK A DOBBS
Regulation Number890.5720
Classification Product Code
ILO  
Date Received11/04/1994
Decision Date 03/07/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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