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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 K935982
Device Name SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS
Applicant
C.M.D. Acupuncture Center
1644 Bridge St.
Philadelphia,  PA  19124
Applicant Contact BIHONG GUAN
Correspondent
C.M.D. Acupuncture Center
1644 Bridge St.
Philadelphia,  PA  19124
Correspondent Contact BIHONG GUAN
Regulation Number890.5500
Classification Product Code
ILY  
Date Received12/14/1993
Decision Date 03/24/1995
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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