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FDA 510(k)

DURETTE OCULAR IMPLANT

K-Number: K123764 · 2013-01-31

ApplicantOculo-Plastik, Inc.
Decision Date2013-01-31
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DURETTE OCULAR IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Oculo-Plastik, Inc.. It received FDA 510(k) clearance on 2013-01-31 under 510(k) number K123764. The device is classified under product code HPZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURETTE OCULAR IMPLANT?

DURETTE OCULAR IMPLANT is a medical device that received FDA 510(k) clearance on 2013-01-31. The listed applicant is Oculo-Plastik, Inc.. The 510(k) number is K123764.

When did DURETTE OCULAR IMPLANT receive FDA 510(k) clearance?

DURETTE OCULAR IMPLANT received FDA 510(k) clearance on 2013-01-31, under 510(k) number K123764.

Who is the listed applicant for DURETTE OCULAR IMPLANT?

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

What is the FDA product code for DURETTE OCULAR IMPLANT?

The FDA product code for DURETTE OCULAR IMPLANT is HPZ.

Related Clinical Trials

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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Other records listing Oculo-Plastik, 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.

K112176SILICONE SPHERESK073293DURETTE IMPLANTK040689EYE SPHERE IMPLANTSK934834EPTFE SHEET COVERING FOR OCULAR IMPLANTK915630OPHTIMPLANTK901002O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES

View all 13 devices →

Related Devices (Code: HPZ)

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.

K212741EZYPORFci (France Chirurgie Instrumentation) SasK110554BIOCERAMIC ORBITAL IMPLANT, ORBTEXCeramisys, Ltd.K112176SILICONE SPHERESOculo Plastik, Inc.K083342ORBITAL RECONSTRUCTIVE IMPLANT IIEvera Medical, Inc.K082850EYE SPHERESProduct and Educational Services, LLCK073293DURETTE IMPLANTOculo Plastik, Inc.

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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