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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 K935995
Device Name HAND-HELD HEAT APPLICATOR
Applicant
Avon Products, Inc.
One Astor Plz.
1515 Broadway, 43rd Floor
New York,  NY  10036
Applicant Contact DAVID A EISEN
Correspondent
Avon Products, Inc.
One Astor Plz.
1515 Broadway, 43rd Floor
New York,  NY  10036
Correspondent Contact DAVID A EISEN
Regulation Number890.5500
Classification Product Code
ILY  
Date Received12/15/1993
Decision Date 06/09/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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