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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 K081791
FOIA Releasable 510(k) K081791
Device Name E-Z CLEAN ELECTROSURGICAL ELECTRODE
Applicant
MEGADYNE MEDICAL PRODUCTS, INC.
11506 SOUTH STATE ST.
DRAPER,  UT  84020
Applicant Contact RONDA K MAGNESON
Correspondent
MEGADYNE MEDICAL PRODUCTS, INC.
11506 SOUTH STATE ST.
DRAPER,  UT  84020
Correspondent Contact RONDA K MAGNESON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/25/2008
Decision Date 10/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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