PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE— 510(k) K000151

Name: FDA 510(k) clearance K000151
Creator: U.S. Food and Drug Administration
Published: 2000-04-10

Substantially Equivalent

Integrated Orbital Implants, Inc.

FDA 510(k) clearance K000151 for PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE, Substantially Equivalent on 2000-04-10. Applicant: Integrated Orbital Implants, Inc.. Device class: 2.

Clearance details

Applicant: Integrated Orbital Implants, Inc.
Product code: Code MQU
Device class: Class 2
Regulation: 21 CFR 886.3320
Advisory panel: Ophthalmic
Date received: 2000-01-19
Decision date: 2000-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQU

view all

K980822 — TITANIUM PEG SYSTEM1998-07-09
K974203 — PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM1998-02-04
K971583 — MEDPOR OCULAR SCREW AND ACCEOSSORIES1997-06-30

More clearances from Integrated Orbital Implants, Inc.

view all

K003338 — BIO-EYE II ORBITAL IMPLANT2001-02-07
K982562 — BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER1998-12-28
K891137 — MOTILITY ORBITAL IMPLANT1989-08-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.