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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 K851318
Device Name GUIBOR MICROELECTROLYSIS UNIT 18
Applicant
Galvanic Medical Instruments, Inc.
P.O. Box 1042
Paramus,  NJ  07652
Applicant Contact DAVID
Correspondent
Galvanic Medical Instruments, Inc.
P.O. Box 1042
Paramus,  NJ  07652
Correspondent Contact DAVID
Regulation Number878.5350
Classification Product Code
KCW  
Date Received04/02/1985
Decision Date 08/20/1985
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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