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FDA 510(k)

OPTIKEM PMMA CONTACT LENS

K-Number: K895411 · 1990-02-27

ApplicantOptikem Polymers, Inc.
Decision Date1990-02-27
Product CodeHPX
DecisionSubstantially Equivalent

Device Summary

OPTIKEM PMMA CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Optikem Polymers, Inc.. It received FDA 510(k) clearance on 1990-02-27 under 510(k) number K895411. The device is classified under product code HPX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIKEM PMMA CONTACT LENS?

OPTIKEM PMMA CONTACT LENS is a medical device that received FDA 510(k) clearance on 1990-02-27. The listed applicant is Optikem Polymers, Inc.. The 510(k) number is K895411.

When did OPTIKEM PMMA CONTACT LENS receive FDA 510(k) clearance?

OPTIKEM PMMA CONTACT LENS received FDA 510(k) clearance on 1990-02-27, under 510(k) number K895411.

Who is the listed applicant for OPTIKEM PMMA CONTACT LENS?

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

What is the FDA product code for OPTIKEM PMMA CONTACT LENS?

The FDA product code for OPTIKEM PMMA CONTACT LENS is HPX.

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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Related Devices (Code: HPX)

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.

K955777PMMA CLASICRand Scientific Corp.K940106KERATOPLASTY SUTURING LENSVisionary Technologies of Miami, Inc.K913081MULTI-VIEW BIFOCALSCamp Contact LensesK897021MARTIN-HENSLEY SEGMENT LENSBruce W. Martin O.D. and Edward HensleyK874591ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERYVitreo Dynamics, Co.K865111CHARTER HARD CONTACT LENS CLEANING SOLUTIONPaco Pharmaceutical Services, Inc.

Official Source

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

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