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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 K904015
Device Name ELECTRO-BLEND EPILATOR, MODEL UC-3
Applicant
A.R. Hinkel Co., Inc.
18121-C Parthenia St.
Northridge,  CA  91325
Applicant Contact WILLIAM A SCHULER
Correspondent
A.R. Hinkel Co., Inc.
18121-C Parthenia St.
Northridge,  CA  91325
Correspondent Contact WILLIAM A SCHULER
Regulation Number878.5350
Classification Product Code
KCW  
Date Received08/31/1990
Decision Date 10/04/1990
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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