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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 K934262
Device Name HPRH HOSPITAL PATIENT RADIANT HEATER
Applicant
Marley Electric Heating Co.
470 Beauty Spot Rd. E
Bennettsville,  SC  29512
Applicant Contact ERNEST R AROVITS
Correspondent
Marley Electric Heating Co.
470 Beauty Spot Rd. E
Bennettsville,  SC  29512
Correspondent Contact ERNEST R AROVITS
Regulation Number890.5720
Classification Product Code
ILO  
Date Received08/31/1993
Decision Date 04/18/1995
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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