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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 K012129
Device Name ORTHO DEVELOPMENT ORION-I EMF SYSTEM
Applicant
Ortho Development Corp.
106 W. 12200 S.
Draper,  UT  84020
Applicant Contact CAROL FREASIER
Correspondent
Underwriters Laboratories, Inc.
1655 Scott Blvd.
Santa Clara,  CA  95050
Correspondent Contact MICHAEL KWAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/09/2001
Decision Date 08/22/2001
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
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