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510(k) K021643

HA ORBITAL IMPLANT by Laboratoire Villanova — Product Code HPZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2002
Date Received
May 20, 2002
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

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  • 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)