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510(k) K130131

EDRAIN CHEST DRAINAGE SYSTEM by Atrium Medical Corp. — Product Code BTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2013
Date Received
January 18, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

Other clearances by Atrium Medical Corp.

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  • K102596 — ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT (October 5, 2010)
  • K093431 — CLEARWAY OTW MODEL 85912 (April 20, 2010)
  • K100076 — ATRIUM C-QUR OVT MESH (January 26, 2010)
  • K090909 — C-QUR V -PATCH MESH (June 4, 2009)
  • K082748 — ATRIUM PROLITE S MESH (January 14, 2009)
  • K081718 — EXPRESS CHEST DRAIN (July 25, 2008)
  • K080688 — C-QUR LITE MESH V-PATCH (April 16, 2008)

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