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FDA 510(k)

KOLBERG OPHTHALMIC CONFORMER

K-Number: K945110 · 1995-01-13

ApplicantKolberg Ocular Products, Inc.
Decision Date1995-01-13
Product CodeHQN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOLBERG OPHTHALMIC CONFORMER is the device name listed in this FDA 510(k) record. The listed applicant is Kolberg Ocular Products, Inc.. It received FDA 510(k) clearance on 1995-01-13 under 510(k) number K945110. The device is classified under product code HQN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOLBERG OPHTHALMIC CONFORMER?

KOLBERG OPHTHALMIC CONFORMER is a medical device that received FDA 510(k) clearance on 1995-01-13. The listed applicant is Kolberg Ocular Products, Inc.. The 510(k) number is K945110.

When did KOLBERG OPHTHALMIC CONFORMER receive FDA 510(k) clearance?

KOLBERG OPHTHALMIC CONFORMER received FDA 510(k) clearance on 1995-01-13, under 510(k) number K945110.

Who is the listed applicant for KOLBERG OPHTHALMIC CONFORMER?

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

What is the FDA product code for KOLBERG OPHTHALMIC CONFORMER?

The FDA product code for KOLBERG OPHTHALMIC CONFORMER is HQN.

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Related Devices (Code: HQN)

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.

K972034MEDPOR OCULAR CONFORMERPorex Surgical, Inc.K970319OCULAR CONFORMERXavier A. Guerra, Ocularist, Inc.K970318OCULAR CONFORMERSouthwest Artificial Eyes, Inc.K921221STERILE/SINGLE USE SYMBLEPHARON RINGStorz Instrument Co.K921229STERILE/SINGLE USE OPHTHALMIC CONFORMERSStorz Instrument Co.K772168MOLDEYERobert B. Scott Ocularists of Florida, Inc.

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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