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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 K892514
Device Name AHRS EPILATOR 629
Applicant
American Hair Removal System Co.
160 S. May St.
Southern Pines,  NC  28387
Applicant Contact LEE COLE
Correspondent
American Hair Removal System Co.
160 S. May St.
Southern Pines,  NC  28387
Correspondent Contact LEE COLE
Regulation Number878.5360
Classification Product Code
KCX  
Date Received04/11/1989
Decision Date 08/14/1990
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
Predetermined Change
Control Plan Authorized		 No
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