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FDA 510(k)

EPTFE SHEET COVERING FOR OCULAR IMPLANT

K-Number: K934834 · 1994-05-05

ApplicantOculo Plastik, Inc.
Decision Date1994-05-05
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EPTFE SHEET COVERING FOR 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 1994-05-05 under 510(k) number K934834. 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 EPTFE SHEET COVERING FOR OCULAR IMPLANT?

EPTFE SHEET COVERING FOR OCULAR IMPLANT is a medical device that received FDA 510(k) clearance on 1994-05-05. The listed applicant is Oculo Plastik, Inc.. The 510(k) number is K934834.

When did EPTFE SHEET COVERING FOR OCULAR IMPLANT receive FDA 510(k) clearance?

EPTFE SHEET COVERING FOR OCULAR IMPLANT received FDA 510(k) clearance on 1994-05-05, under 510(k) number K934834.

Who is the listed applicant for EPTFE SHEET COVERING FOR 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 EPTFE SHEET COVERING FOR OCULAR IMPLANT?

The FDA product code for EPTFE SHEET COVERING FOR OCULAR IMPLANT is HPZ.

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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 SPHERESK073293DURETTE IMPLANTK040689EYE SPHERE IMPLANTSK915630OPHTIMPLANTK901002O'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) 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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