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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Surgical Instrument, Ac-Powered
510(k) Number K904682
Device Name VISTEK ELECTRONIC CONTROLLER
Applicant
Vistek Corp.
70 Santa Felicia Dr.
Goleta,  CA  93117
Applicant Contact RICHARD MULLARKY
Correspondent
Vistek Corp.
70 Santa Felicia Dr.
Goleta,  CA  93117
Correspondent Contact RICHARD MULLARKY
Regulation Number878.4820
Classification Product Code
GEY  
Date Received10/15/1990
Decision Date 12/18/1990
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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