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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 K875052
Device Name TDP, LARK BRAND AND MIT LAMP
Applicant
I.E.C. Co.
1450 E. 17th St.
Suite 122
Santa Ana,  CA  92701
Applicant Contact EUGENE Y HU
Correspondent
I.E.C. Co.
1450 E. 17th St.
Suite 122
Santa Ana,  CA  92701
Correspondent Contact EUGENE Y HU
Regulation Number890.5500
Classification Product Code
ILY  
Date Received12/09/1987
Decision Date 06/23/1988
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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