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510(k) K070192

ATRIUM PROLITE ULTRA S MESH by Atrium Medical Corp. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2007
Date Received
January 22, 2007
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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  • K082748 — ATRIUM PROLITE S MESH (January 14, 2009)
  • K081718 — EXPRESS CHEST DRAIN (July 25, 2008)

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