Medpor Ocular Conformer

• • Terminated Z-2302-2008 FDA Unclassified (pre-2012) ·initiated 28 Mar 2008

  The Ocular Conformers were distributed with an expired expiration date.

510(k) Number

K972034 ↗

FDA Product Code

HQN

Device Class

Class II

Regulation

21 CFR Part 886.3130

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Medpor Surgical Granule Implants

  Class II

  FDA 510(k) K982040 Active Cleared 8 Sep 1998

• Porex Nostril Retainers

  Class I

  FDA 510(k) K981374 Active Cleared 2 Jul 1998

• Medpor Quad Motility Implant

  Class II

  FDA 510(k) K010902 Active Cleared 19 Jun 2001

• Medpor Surgical Implant Material

  Class II

  FDA 510(k) K943275 Active Cleared 2 Sep 1994

• Medpor Craniofacial Implants with Embedded Titanium Mesh

  Class II

  FDA 510(k) K040364 Active Cleared 30 Jun 2004

• Medpor Plus Orbital Volume Replacement Impant

  Class II

  FDA 510(k) K021357 Active Cleared 5 Aug 2002

See all devices from Porex Surgical, Inc. →