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510(k) K863943

POREX(TM) EYE SPHERE IMPLANT by Porex Medical — Product Code HPZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1987
Date Received
October 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Sphere
Device Class
Class II
Regulation Number
886.3320
Review Panel
OP
Submission Type

Other clearances by Porex Medical

  • K872791 — POREX NERVE LOCATOR (October 20, 1987)
  • K873044 — POREX OTOLOGY INSTRUMENTS (September 4, 1987)
  • K872947 — POREX QUALITY PLASTIC SURGERY INSTRUMENTS (August 21, 1987)
  • K863946 — POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT (February 27, 1987)
  • K870154 — POREX(TM) TISSUE EXPANDER (February 24, 1987)
  • K870257 — POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T. (February 24, 1987)
  • K870182 — POREX(TM) MALAR IMPLANT (February 24, 1987)
  • K863939 — POREX(TM) EAR PROSTHESIS (October 24, 1986)
  • K863942 — POREX(TM) NOSE PROSTHESIS (October 24, 1986)
  • K863941 — POREX(TM) PROSTHESIS, CHIN, INTERNAL (October 24, 1986)

Other clearances for product code HPZ

  • K212741 — EZYPOR (June 24, 2022)
  • K123764 — DURETTE OCULAR IMPLANT (January 31, 2013)
  • K110554 — BIOCERAMIC ORBITAL IMPLANT, ORBTEX (November 2, 2011)
  • K112176 — SILICONE SPHERES (September 15, 2011)
  • K083342 — ORBITAL RECONSTRUCTIVE IMPLANT II (March 12, 2009)
  • K082850 — EYE SPHERES (February 27, 2009)
  • K073293 — DURETTE IMPLANT (March 19, 2008)
  • K071335 — MEDPOR ATTRACTOR IMPLANT (August 8, 2007)
  • K070130 — ORBITAL RECONSTRUCTIVE IMPLANT (April 19, 2007)
  • K053298 — ALPHASPHERE ORBITAL IMPLANT (May 9, 2006)