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FDA 510(k)

SILICONE PUNCTAL PLUG

K-Number: K980437 · 1998-04-30

ApplicantOasis Medical, Inc.
Decision Date1998-04-30
Product CodeLZU
DecisionSubstantially Equivalent

Device Summary

SILICONE PUNCTAL 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 1998-04-30 under 510(k) number K980437. The device is classified under product code LZU. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE PUNCTAL PLUG?

SILICONE PUNCTAL PLUG is a medical device that received FDA 510(k) clearance on 1998-04-30. The listed applicant is Oasis Medical, Inc.. The 510(k) number is K980437.

When did SILICONE PUNCTAL PLUG receive FDA 510(k) clearance?

SILICONE PUNCTAL PLUG received FDA 510(k) clearance on 1998-04-30, under 510(k) number K980437.

Who is the listed applicant for SILICONE PUNCTAL 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 SILICONE PUNCTAL PLUG?

The FDA product code for SILICONE PUNCTAL PLUG is LZU.

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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 PlugK162361Soft Plug Extended Duration 180 Canalicular PlugK032297DISPOSABLE N-PE MICKROKERATOME BLADESK030401DISPOSABLE M2-PE MICROKERATOME BLADESK022205DISPOSABLE N-PE MICROKERATOME BLADESK013613SOFT PLUG ABSORBABLE PLUG-SA

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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.

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.K162361Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc.K161673LacriPro Punctum PlugLacrimedics, 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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