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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 K943928
Device Name APILUS ELECTROPIL
Applicant
Dectro Intl., Inc.
2065 Boul Charest O.
Sainte-Foy (Quebec),  CA G1N 2G1
Applicant Contact DENIS BOURGAULT
Correspondent
Dectro Intl., Inc.
2065 Boul Charest O.
Sainte-Foy (Quebec),  CA G1N 2G1
Correspondent Contact DENIS BOURGAULT
Regulation Number878.5350
Classification Product Code
KCW  
Date Received08/12/1994
Decision Date 01/12/1995
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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