ATRIUM 2000, CHEST DRAIN

Bottle, Collection, Vacuum

ATRIUM MEDICAL CORP.

The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium 2000, Chest Drain.

Pre-market Notification Details

Device IDK897125
510k NumberK897125
Device Name:ATRIUM 2000, CHEST DRAIN
ClassificationBottle, Collection, Vacuum
Applicant ATRIUM MEDICAL CORP. 17 CLINTON DR. Hollis,  NH  03049
ContactTed Karwoski
CorrespondentTed Karwoski
ATRIUM MEDICAL CORP. 17 CLINTON DR. Hollis,  NH  03049
Product CodeKDQ  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-26
Decision Date1990-03-30

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