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FDA 510(k)

LE CASE HARD CONTACT LENS STORAGE CASE

K-Number: K822495 · 1982-09-30

ApplicantOptikem International, Inc.
Decision Date1982-09-30
Product CodeHPX
DecisionSubstantially Equivalent

Device Summary

LE CASE HARD CONTACT LENS STORAGE CASE is the device name listed in this FDA 510(k) record. The listed applicant is Optikem International, Inc.. It received FDA 510(k) clearance on 1982-09-30 under 510(k) number K822495. The device is classified under product code HPX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LE CASE HARD CONTACT LENS STORAGE CASE?

LE CASE HARD CONTACT LENS STORAGE CASE is a medical device that received FDA 510(k) clearance on 1982-09-30. The listed applicant is Optikem International, Inc.. The 510(k) number is K822495.

When did LE CASE HARD CONTACT LENS STORAGE CASE receive FDA 510(k) clearance?

LE CASE HARD CONTACT LENS STORAGE CASE received FDA 510(k) clearance on 1982-09-30, under 510(k) number K822495.

Who is the listed applicant for LE CASE HARD CONTACT LENS STORAGE CASE?

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

What is the FDA product code for LE CASE HARD CONTACT LENS STORAGE CASE?

The FDA product code for LE CASE HARD CONTACT LENS STORAGE CASE 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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Other records listing Optikem International, 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.

K071203SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES

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 HensleyK895411OPTIKEM PMMA CONTACT LENSOptikem Polymers, Inc.K874591ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERYVitreo Dynamics, Co.

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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