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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name epilator, high frequency, tweezer-type
510(k) Number K905125
Device Name GUARANTY HAIR REMOVAL SYSTEM
Applicant
STEPHENS MFG. CO.
C/O HOGAN & HARTSON
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
STEPHENS MFG. CO.
C/O HOGAN & HARTSON
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number878.5360
Classification Product Code
KCX  
Date Received11/14/1990
Decision Date 08/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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