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510(k) K000151

PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE by Integrated Orbital Implants, Inc. — Product Code MQU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2000
Date Received
January 19, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ocular Peg
Device Class
Class II
Regulation Number
886.3320
Review Panel
OP
Submission Type

Other clearances by Integrated Orbital Implants, Inc.

  • K003338 — BIO-EYE II ORBITAL IMPLANT (February 7, 2001)
  • K982562 — BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER (December 28, 1998)
  • K974203 — PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM (February 4, 1998)
  • K891137 — MOTILITY ORBITAL IMPLANT (August 24, 1989)

Other clearances for product code MQU

  • K980822 — TITANIUM PEG SYSTEM (July 9, 1998)
  • K974203 — PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM (February 4, 1998)
  • K971583 — MEDPOR OCULAR SCREW AND ACCEOSSORIES (June 30, 1997)