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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 K024304
Device Name MICROSURGICAL BIPOLAR HANDPIECE
Applicant
Neomedix Corp.
27452 Calle Arroyo
San Juan Capistrano,  CA  92675 -2748
Applicant Contact SOHEILA MIRHASEMI
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact ROBERT M BOONSTRA
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HQR  
Date Received12/24/2002
Decision Date 02/25/2003
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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