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510(k) K972034

MEDPOR OCULAR CONFORMER by Porex Surgical, Inc. — Product Code HQN

K972034 is an FDA 510(k) premarket notification submitted by Porex Surgical, Inc. for the device "MEDPOR OCULAR CONFORMER". The FDA issued a decision of Substantially Equivalent on January 20, 1998. The device falls under product code HQN (Conformer, Ophthalmic), a Class II device regulated under 21 CFR 886.3130. Porex Surgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1998
Date Received
June 2, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conformer, Ophthalmic
Device Class
Class II
Regulation Number
886.3130
Review Panel
OP
Submission Type

Other clearances by Porex Surgical, Inc.

  • K102184 — MEDPOR CONTAIN CAN IMPLANT (January 7, 2011)
  • K101835 — MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 (December 3, 2010)
  • K091807 — MEDPOR FIXATION SYSTEM (June 28, 2010)
  • K091120 — MEDPOR CONTAIN IMPLANT (March 19, 2010)
  • K083621 — MEDPOR CUSTOMIZED SURGICAL IMPLANT (February 3, 2009)
  • K071335 — MEDPOR ATTRACTOR IMPLANT (August 8, 2007)
  • K052297 — POREX ELECTROSURGERY NEEDLE (March 28, 2006)
  • K040851 — MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM (July 16, 2004)
  • K040364 — MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH (June 30, 2004)
  • K021357 — MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT (August 5, 2002)

Other clearances for product code HQN

  • K970318 — OCULAR CONFORMER (July 7, 1997)
  • K970319 — OCULAR CONFORMER (July 7, 1997)
  • K945110 — KOLBERG OPHTHALMIC CONFORMER (January 13, 1995)
  • K921221 — STERILE/SINGLE USE SYMBLEPHARON RING (July 17, 1992)
  • K921229 — STERILE/SINGLE USE OPHTHALMIC CONFORMERS (June 9, 1992)
  • K772168 — MOLDEYE (November 30, 1977)

FDA data resources