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510(k) K131007

AIGIS RX N MEDIUM; AIGIS RX N LARGE by Tyrx, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2013
Date Received
April 11, 2013
Clearance Type
Traditional
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

Other clearances by Tyrx, Inc.

  • K152678 — TYRX Neuro Antibacterial Envelope (November 17, 2015)
  • K132699 — AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) (November 26, 2013)
  • K130943 — AIGIS RX R PM/ AIGIS RX R ICD (May 20, 2013)
  • K093524 — PIVIT A/B ST AND PIVIT A/B ST-R (March 26, 2010)

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