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510(k) K093524

PIVIT A/B ST AND PIVIT A/B ST-R by Tyrx, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2010
Date Received
November 16, 2009
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

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  • K130943 — AIGIS RX R PM/ AIGIS RX R ICD (May 20, 2013)

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