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510(k) K142192

Insightra Freedom Ventral Hernia Repair System by Insightra Medical — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2015
Date Received
August 11, 2014
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

  • K140967 — FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK (June 10, 2014)
  • K113552 — FREEDOM INGUINAL HERNIA IMPLANT (August 23, 2012)
  • K082746 — ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 (January 12, 2009)

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