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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 K874891
Device Name FLEXIE THE COPPER SHANK NEEDLE
Applicant
SKIN DEEP, INC.
1926 COTTMAN AVE.
PHILADELPHIA,  PA  19111
Applicant Contact KATHERINE LASKER
Correspondent
SKIN DEEP, INC.
1926 COTTMAN AVE.
PHILADELPHIA,  PA  19111
Correspondent Contact KATHERINE LASKER
Regulation Number878.5350
Classification Product Code
KCW  
Date Received12/01/1987
Decision Date 01/07/1988
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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