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510(k) K781356

IMPLANT, EYE SPHERE by Mcghan Medical Corp. — Product Code HPZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1978
Date Received
August 7, 1978
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 Mcghan Medical Corp.

  • K873476 — MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS (September 11, 1987)
  • K873475 — MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS (September 11, 1987)
  • K870754 — MCGHAN TISSUE EXPANDER FILL SYSTEM (March 31, 1987)
  • K864184 — MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN (December 24, 1986)
  • K864185 — MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN (December 24, 1986)
  • K862203 — MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER (July 23, 1986)
  • K854794 — MCGHAN INTEGRAL VALVE TISSUE EXPANDER (December 24, 1985)
  • K853014 — MCGHAN TISSUE EXPANDER FILL KIT (September 18, 1985)
  • K843704 — MCGHAN TISSUE EXPANDER (October 31, 1984)
  • K781087 — MEDICAL GRADE SILICONE ELASTOMER TUBING (November 22, 1978)

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)