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FDA 510(k)

DURETTE IMPLANT

K-Number: K073293 · 2008-03-19

ApplicantOculo Plastik, Inc.
Decision Date2008-03-19
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DURETTE 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 2008-03-19 under 510(k) number K073293. 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 IMPLANT?

DURETTE IMPLANT is a medical device that received FDA 510(k) clearance on 2008-03-19. The listed applicant is Oculo Plastik, Inc.. The 510(k) number is K073293.

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

DURETTE IMPLANT received FDA 510(k) clearance on 2008-03-19, under 510(k) number K073293.

Who is the listed applicant for DURETTE 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 IMPLANT?

The FDA product code for DURETTE 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.

K123764DURETTE OCULAR IMPLANTK112176SILICONE SPHERESK040689EYE SPHERE IMPLANTSK934834EPTFE SHEET COVERING FOR OCULAR IMPLANTK915630OPHTIMPLANTK901002O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES

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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) SasK123764DURETTE OCULAR IMPLANTOculo-Plastik, Inc.K110554BIOCERAMIC ORBITAL IMPLANT, ORBTEXCeramisys, Ltd.K112176SILICONE SPHERESOculo Plastik, Inc.K083342ORBITAL RECONSTRUCTIVE IMPLANT IIEvera Medical, Inc.K082850EYE SPHERESProduct and Educational Services, LLC

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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