ATRIUM MEDICAL CORPORATION EXPRESS 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 Medical Corporation Express Chest Drain.

Pre-market Notification Details

Device IDK984496
510k NumberK984496
Device Name:ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
ClassificationBottle, Collection, Vacuum
Applicant ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
ContactJoseph P Depaolo
CorrespondentJoseph P Depaolo
ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
Product CodeKDQ  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-12-17
Decision Date1999-05-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20650862164002 K984496 000
20650862161001 K984496 000

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