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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 K843734
Device Name NEMDI
Applicant
Nemectron Medical, Inc.
28069 Diaz Rd. Unit A
Temecula,  CA  92590
Applicant Contact JUERGEN F KOPF
Correspondent
Nemectron Medical, Inc.
28069 Diaz Rd. Unit A
Temecula,  CA  92590
Correspondent Contact JUERGEN F KOPF
Regulation Number878.5360
Classification Product Code
KCX  
Date Received09/24/1984
Decision Date 10/25/1984
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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