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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K973234
Device Name MIDAS TOUCH ELECTROSURGICAL ELECTRODE
Applicant
ITI MEDICAL TECHNOLOGIES, INC.
2452 ARMSTRONG ST.
LIVERMORE,  CA  94550
Applicant Contact ROGER WERNE
Correspondent
ITI MEDICAL TECHNOLOGIES, INC.
2452 ARMSTRONG ST.
LIVERMORE,  CA  94550
Correspondent Contact ROGER WERNE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/28/1997
Decision Date 10/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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