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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 K864289
Device Name MICROPROCESSOR CONTR/MULTI-NEEDLE, GALVAN EPILATOR
Applicant
ALEXANDER THOMAS, INC.
120-2A PACIFIC AVE.
COLLINGSWOOD,  NJ  08108
Applicant Contact THOMAS GUERRIERI
Correspondent
ALEXANDER THOMAS, INC.
120-2A PACIFIC AVE.
COLLINGSWOOD,  NJ  08108
Correspondent Contact THOMAS GUERRIERI
Regulation Number878.5350
Classification Product Code
KCW  
Date Received10/31/1986
Decision Date 12/01/1986
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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