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510(k) K080691

C-QUR EDGE MESH V-PATCH by Atrium Medical Corp. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2008
Date Received
March 11, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Polymeric
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

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  • K093431 — CLEARWAY OTW MODEL 85912 (April 20, 2010)
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  • K090909 — C-QUR V -PATCH MESH (June 4, 2009)
  • K082748 — ATRIUM PROLITE S MESH (January 14, 2009)
  • K081718 — EXPRESS CHEST DRAIN (July 25, 2008)

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