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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 K851413
Device Name EPILATOR 8500
Applicant
Lois Yee Cosmetics, Inc.
1850 S. Eldorado St.
P.O. Box 6188
Stockton,  CA  95206
Applicant Contact K YEE
Correspondent
Lois Yee Cosmetics, Inc.
1850 S. Eldorado St.
P.O. Box 6188
Stockton,  CA  95206
Correspondent Contact K YEE
Regulation Number878.5360
Classification Product Code
KCX  
Date Received04/09/1985
Decision Date 06/10/1985
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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