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510(k) K984496

ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN by Atrium Medical Corp. — Product Code KDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1999
Date Received
December 17, 1998
Clearance Type
Traditional
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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  • K941818 — PM9000 VAC TRAP (December 12, 1994)
  • K932327 — THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM (July 13, 1993)
  • K912704 — ATRIUM 2000 CHEST DRAIN (August 26, 1991)