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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 K902803
Device Name A PHYSIOTHERAPY APPARATUS
Applicant
Grace River Ent., Inc.
155 E. 31 St., Suite 10k
New York,  NY  10016
Applicant Contact GRACE SHIH
Correspondent
Grace River Ent., Inc.
155 E. 31 St., Suite 10k
New York,  NY  10016
Correspondent Contact GRACE SHIH
Regulation Number890.5500
Classification Product Code
ILY  
Date Received06/27/1990
Decision Date 02/06/1991
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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