EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET

Pump, Portable, Aspiration (manual Or Powered)

APPLIED MEDICAL

The following data is part of a premarket notification filed by Applied Medical with the FDA for Epix Irrigation Pump, Epix Suction Irrigation Tubing Set.

Pre-market Notification Details

Device IDK122619
510k NumberK122619
Device Name:EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET
ClassificationPump, Portable, Aspiration (manual Or Powered)
Applicant APPLIED MEDICAL 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
ContactJessica Cho
CorrespondentJessica Cho
APPLIED MEDICAL 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
Product CodeBTA  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-28
Decision Date2012-10-02
Summary:summary

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