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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 K050579
Device Name MEGA POWER ELECTROSURGICAL GENERATOR
Applicant
Megadyne Medical Products, Inc.
11506 S. State St.
Draper,  UT  84020
Applicant Contact RONDA K MAGNESON
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/07/2005
Decision Date 03/24/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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