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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 K924518
Device Name BODY SOOTHER
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 Number890.5660
Classification Product Code
ISA  
Date Received09/04/1992
Decision Date 10/12/1993
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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