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FDA 510(k)

Soft Plug Extended Duration 180 Canalicular Plug

K-Number: K162361 · 2017-04-17

ApplicantOasis Medical, Inc.
Decision Date2017-04-17
Product CodeLZU
DecisionSubstantially Equivalent

Device Summary

Soft Plug Extended Duration 180 Canalicular Plug is the device name listed in this FDA 510(k) record. The listed applicant is Oasis Medical, Inc.. It received FDA 510(k) clearance on 2017-04-17 under 510(k) number K162361. The device is classified under product code LZU. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Soft Plug Extended Duration 180 Canalicular Plug?

Soft Plug Extended Duration 180 Canalicular Plug is a medical device that received FDA 510(k) clearance on 2017-04-17. The listed applicant is Oasis Medical, Inc.. The 510(k) number is K162361.

When did Soft Plug Extended Duration 180 Canalicular Plug receive FDA 510(k) clearance?

Soft Plug Extended Duration 180 Canalicular Plug received FDA 510(k) clearance on 2017-04-17, under 510(k) number K162361.

Who is the listed applicant for Soft Plug Extended Duration 180 Canalicular Plug?

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

What is the FDA product code for Soft Plug Extended Duration 180 Canalicular Plug?

The FDA product code for Soft Plug Extended Duration 180 Canalicular Plug is LZU.

Other records listing Oasis Medical, 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.

K213988SOFT PLUG Extended Duration 180 Tapered Canalicular Plug

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.

K241229Hello,eyes® BIO PlugBio Optics Co., Ltd.K222164Visant Medical Canalicular PlugVisant Medical, Inc.K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc.K190210Tear Pool Dissolvable Punctum PlugsAlphamed, Inc.K161673LacriPro Punctum PlugLacrimedics, 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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