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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K854151
Device Name HOMECARE CLINICS INFRAHEAT #230
Applicant
Nelkin/Piper Intl.
811 Wyandotte
P.O. Box 807
Kansas City,  MO  64105
Applicant Contact MARC BERNSTEIN
Correspondent
Nelkin/Piper Intl.
811 Wyandotte
P.O. Box 807
Kansas City,  MO  64105
Correspondent Contact MARC BERNSTEIN
Regulation Number890.5500
Classification Product Code
ILY  
Date Received10/11/1985
Decision Date 01/30/1986
Decision Substantially Equivalent (SESE)
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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