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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 K782119
Device Name DEBUTRON
Applicant
Martin Electric Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Martin Electric Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.5360
Classification Product Code
KCX  
Date Received12/27/1978
Decision Date 02/26/1979
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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