OCEAN 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 Ocean Chest Drain.

Pre-market Notification Details

Device IDK043582
510k NumberK043582
Device Name:OCEAN CHEST DRAIN
ClassificationBottle, Collection, Vacuum
Applicant ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
ContactJoseph P De Paolo
CorrespondentJoseph P De Paolo
ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
Product CodeKDQ  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-28
Decision Date2005-01-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20650862104039 K043582 000
20650862100048 K043582 000
20650862100062 K043582 000
20650862100093 K043582 000
20650862100109 K043582 000
20650862100192 K043582 000
20650862100215 K043582 000
20650862100321 K043582 000
20650862100345 K043582 000
20650862101021 K043582 000
20650862101038 K043582 000
20650862102011 K043582 000
20650862102042 K043582 000
20650862102059 K043582 000
20650862103018 K043582 000
20650862103032 K043582 000
20650862103063 K043582 000
20650862104015 K043582 000
20650862100017 K043582 000

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