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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, needle-type
510(k) Number K895687
Device Name D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE)
Applicant
CAROL BLOCK, LTD.
7701 BULL VALLEY RD.
MC HENRY,  IL  60050
Applicant Contact CAROL BLOCK
Correspondent
CAROL BLOCK, LTD.
7701 BULL VALLEY RD.
MC HENRY,  IL  60050
Correspondent Contact CAROL BLOCK
Regulation Number878.5350
Classification Product Code
KCW  
Date Received09/22/1989
Decision Date 08/09/1990
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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