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510(k) K043582

OCEAN CHEST DRAIN by Atrium Medical Corp. — Product Code KDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2005
Date Received
December 28, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bottle, Collection, Vacuum
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

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  • K912704 — ATRIUM 2000 CHEST DRAIN (August 26, 1991)