EDRAIN CHEST DRAINAGE SYSTEM

Pump, Portable, Aspiration (manual Or Powered)

ATRIUM MEDICAL CORP.

The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Edrain Chest Drainage System.

Pre-market Notification Details

Device IDK130131
510k NumberK130131
Device Name:EDRAIN CHEST DRAINAGE SYSTEM
ClassificationPump, Portable, Aspiration (manual Or Powered)
Applicant ATRIUM MEDICAL CORP. 5 WENTWORTH DR Hudson,  NH  03051
ContactChristina Calderwood
CorrespondentChristina Calderwood
ATRIUM MEDICAL CORP. 5 WENTWORTH DR Hudson,  NH  03051
Product CodeBTA  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-18
Decision Date2013-02-28

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