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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 K952117
Device Name EPILATOR
Applicant
Burke Neutech, Inc.
1765 Commerce Ave. N
St. Petersburg,  FL  33716
Applicant Contact ROBERT E BURKE
Correspondent
Burke Neutech, Inc.
1765 Commerce Ave. N
St. Petersburg,  FL  33716
Correspondent Contact ROBERT E BURKE
Regulation Number878.5360
Classification Product Code
KCX  
Date Received05/05/1995
Decision Date 10/19/1995
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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