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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K911727
Device Name INFRADERM; TOUCH 'N TONE PLUS
Applicant
Conair Corp.
1 Cummings Pt. Rd.
Stamford,  CT  06904
Applicant Contact JAMES H BENNETT
Correspondent
Conair Corp.
1 Cummings Pt. Rd.
Stamford,  CT  06904
Correspondent Contact JAMES H BENNETT
Regulation Number890.5660
Classification Product Code
ISA  
Subsequent Product Code
FNM  
Date Received04/17/1991
Decision Date 02/25/1994
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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