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510(k) K082850

EYE SPHERES by Product and Educational Services, LLC — Product Code HPZ

K082850 is an FDA 510(k) premarket notification submitted by Product and Educational Services, LLC for the device "EYE SPHERES". The FDA issued a decision of Substantially Equivalent on February 27, 2009. The device falls under product code HPZ (Implant, Eye Sphere), a Class II device regulated under 21 CFR 886.3320. Product and Educational Services, LLC has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2009
Date Received
September 29, 2008
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 Product and Educational Services, LLC

  • K941527 — MODEL 2300 GENERAL PURPOSE SUCTION PUMP (May 18, 1994)
  • K941525 — MODEL 2200 THORACIC SUCTION PUMP (May 18, 1994)
  • K941526 — MODEL 2000 MILD INTERMITTENT SUCTION PUMP (May 18, 1994)
  • K941524 — MODEL 2100 MILD INTERMITTENT SUCTION PUMP (May 17, 1994)

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)
  • 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)
  • K040851 — MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM (July 16, 2004)

FDA data resources