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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Pad, Heating, Powered
510(k) Number K924970
Device Name FEMININE HEAT WRAP
Applicant
Conair Corp.
1 Cummings Pt. Rd.
Stamford,  CT  06904
Applicant Contact JEFFREY A WORD
Correspondent
Conair Corp.
1 Cummings Pt. Rd.
Stamford,  CT  06904
Correspondent Contact JEFFREY A WORD
Regulation Number890.5740
Classification Product Code
IRT  
Date Received09/30/1992
Decision Date 10/03/1994
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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