PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM— 510(k) K974203

Name: FDA 510(k) clearance K974203
Creator: U.S. Food and Drug Administration
Published: 1998-02-04

Substantially Equivalent

Integrated Orbital Implants, Inc.

FDA 510(k) clearance K974203 for PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM, Substantially Equivalent on 1998-02-04. 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: 1997-11-10
Decision date: 1998-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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