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FDA 510(k)

LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT

K-Number: K873578 · 1987-11-02

ApplicantOculo-Plastik Reg'D
Decision Date1987-11-02
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Oculo-Plastik Reg'D. It received FDA 510(k) clearance on 1987-11-02 under 510(k) number K873578. 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 LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT?

LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT is a medical device that received FDA 510(k) clearance on 1987-11-02. The listed applicant is Oculo-Plastik Reg'D. The 510(k) number is K873578.

When did LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT receive FDA 510(k) clearance?

LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT received FDA 510(k) clearance on 1987-11-02, under 510(k) number K873578.

Who is the listed applicant for LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT?

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

What is the FDA product code for LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT?

The FDA product code for LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT is HPZ.

Related Clinical Trials

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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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