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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 K954577
Device Name WS FREQUENCY SPECTRUM EFFECT PHYSIATRICS APPARATUS
Applicant
C.A.I. Industries Corp.
307 W. Main St.
Suite 10
Alhambra,  CA  91801
Applicant Contact LU RAO
Correspondent
C.A.I. Industries Corp.
307 W. Main St.
Suite 10
Alhambra,  CA  91801
Correspondent Contact LU RAO
Regulation Number890.5500
Classification Product Code
ILY  
Date Received10/02/1995
Decision Date 05/09/1997
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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