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510(k) K113552

FREEDOM INGUINAL HERNIA IMPLANT by Insightra Medical — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2012
Date Received
December 1, 2011
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 Insightra Medical

  • K142192 — Insightra Freedom Ventral Hernia Repair System (May 7, 2015)
  • K140967 — FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK (June 10, 2014)
  • K082746 — ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 (January 12, 2009)

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