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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 K860056
Device Name BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR)
Applicant
Berkowits School of Electrolysis, Inc.
107-25 Metropolitan Ave.
Forest Hills,  NY  11375
Applicant Contact BARRY HERMAN
Correspondent
Berkowits School of Electrolysis, Inc.
107-25 Metropolitan Ave.
Forest Hills,  NY  11375
Correspondent Contact BARRY HERMAN
Regulation Number878.5350
Classification Product Code
KCW  
Date Received01/06/1986
Decision Date 02/05/1986
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
Predetermined Change
Control Plan Authorized		 No
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