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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 K894771
Device Name EPILATION NEEDLE
Applicant
Precision Electrolysis Needles, Inc.
49 Arnold St.
Riverside,  RI  02915
Applicant Contact CARY, III
Correspondent
Precision Electrolysis Needles, Inc.
49 Arnold St.
Riverside,  RI  02915
Correspondent Contact CARY, III
Regulation Number878.5350
Classification Product Code
KCW  
Date Received07/26/1989
Decision Date 08/21/1989
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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