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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
Model C7000, C7100
Device Name EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET
Original Applicant
APPLIED MEDICAL
22872 avenida empresa
rancho santa margarita,  CA  92688
Original Contact jessica cho
Regulation Number878.4780
Classification Product Code
BTA  
Date Received08/28/2012
Decision Date 10/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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