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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 K132300
Device Name EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE
Applicant
Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa,  CA  92688
Applicant Contact JESSICA CHO
Correspondent
Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa,  CA  92688
Correspondent Contact JESSICA CHO
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/24/2013
Decision Date 01/24/2014
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
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