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510(k) K974203

PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM by Integrated Orbital Implants, Inc. — Product Code MQU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1998
Date Received
November 10, 1997
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)
  • K000151 — PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE (April 10, 2000)
  • K982562 — BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER (December 28, 1998)
  • K891137 — MOTILITY ORBITAL IMPLANT (August 24, 1989)

Other clearances for product code MQU

  • K000151 — PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE (April 10, 2000)
  • K980822 — TITANIUM PEG SYSTEM (July 9, 1998)
  • K971583 — MEDPOR OCULAR SCREW AND ACCEOSSORIES (June 30, 1997)