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FDA 510(k)

TITANIUM PEG SYSTEM

K-Number: K980822 · 1998-07-09

ApplicantFci Ophthalmics, Inc.
Decision Date1998-07-09
Product CodeMQU
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TITANIUM PEG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fci Ophthalmics, Inc.. It received FDA 510(k) clearance on 1998-07-09 under 510(k) number K980822. The device is classified under product code MQU. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITANIUM PEG SYSTEM?

TITANIUM PEG SYSTEM is a medical device that received FDA 510(k) clearance on 1998-07-09. The listed applicant is Fci Ophthalmics, Inc.. The 510(k) number is K980822.

When did TITANIUM PEG SYSTEM receive FDA 510(k) clearance?

TITANIUM PEG SYSTEM received FDA 510(k) clearance on 1998-07-09, under 510(k) number K980822.

Who is the listed applicant for TITANIUM PEG SYSTEM?

The FDA 510(k) record lists Fci Ophthalmics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TITANIUM PEG SYSTEM?

The FDA product code for TITANIUM PEG SYSTEM is MQU.

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Other records listing Fci Ophthalmics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MQU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K000151PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVEIntegrated Orbital Implants, Inc.K974203PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEMIntegrated Orbital Implants, Inc.K971583MEDPOR OCULAR SCREW AND ACCEOSSORIESPorex Technologies Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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