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510(k) K140967

FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK by Insightra Medical — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2014
Date Received
April 14, 2014
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

Other clearances by Insightra Medical

  • K142192 — Insightra Freedom Ventral Hernia Repair System (May 7, 2015)
  • 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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