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FDA 510(k)

HYDROGEL CANALICULAR PLUG

K-Number: K040912 · 2004-11-16

ApplicantPartners IN Biomaterials, Inc.
Decision Date2004-11-16
Product CodeLZU
DecisionSubstantially Equivalent

Device Summary

HYDROGEL CANALICULAR PLUG is the device name listed in this FDA 510(k) record. The listed applicant is Partners IN Biomaterials, Inc.. It received FDA 510(k) clearance on 2004-11-16 under 510(k) number K040912. The device is classified under product code LZU. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROGEL CANALICULAR PLUG?

HYDROGEL CANALICULAR PLUG is a medical device that received FDA 510(k) clearance on 2004-11-16. The listed applicant is Partners IN Biomaterials, Inc.. The 510(k) number is K040912.

When did HYDROGEL CANALICULAR PLUG receive FDA 510(k) clearance?

HYDROGEL CANALICULAR PLUG received FDA 510(k) clearance on 2004-11-16, under 510(k) number K040912.

Who is the listed applicant for HYDROGEL CANALICULAR PLUG?

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

What is the FDA product code for HYDROGEL CANALICULAR PLUG?

The FDA product code for HYDROGEL CANALICULAR PLUG is LZU.

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Related Devices (Code: LZU)

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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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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