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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 K072559
Device Name SUCTION COAGULATOR
Applicant
MEGADYNE MEDICAL PRODUCTS, INC.
11506 SOUTH STATE ST.
DRAPER,  UT  84020
Applicant Contact RONDA MAGNESON
Correspondent
MEGADYNE MEDICAL PRODUCTS, INC.
11506 SOUTH STATE ST.
DRAPER,  UT  84020
Correspondent Contact RONDA MAGNESON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/11/2007
Decision Date 10/05/2007
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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