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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 K942223
Device Name BODY SYSTEM
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 Received05/06/1994
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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