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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K122619
Device Name EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET
Applicant
Applied Medical
22872 Avenida Empresa
Rancho Santa,  CA  92688
Applicant Contact JESSICA CHO
Correspondent
Applied Medical
22872 Avenida Empresa
Rancho Santa,  CA  92688
Correspondent Contact JESSICA CHO
Regulation Number878.4780
Classification Product Code
BTA  
Date Received08/28/2012
Decision Date 10/02/2012
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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