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FDA 510(k)

PUNCTUAL OCCLUDER

K-Number: K970631 · 1997-04-23

ApplicantOdyssey Medical, Inc.
Decision Date1997-04-23
Product CodeLZU
DecisionSubstantially Equivalent

Device Summary

PUNCTUAL OCCLUDER is the device name listed in this FDA 510(k) record. The listed applicant is Odyssey Medical, Inc.. It received FDA 510(k) clearance on 1997-04-23 under 510(k) number K970631. The device is classified under product code LZU. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PUNCTUAL OCCLUDER?

PUNCTUAL OCCLUDER is a medical device that received FDA 510(k) clearance on 1997-04-23. The listed applicant is Odyssey Medical, Inc.. The 510(k) number is K970631.

When did PUNCTUAL OCCLUDER receive FDA 510(k) clearance?

PUNCTUAL OCCLUDER received FDA 510(k) clearance on 1997-04-23, under 510(k) number K970631.

Who is the listed applicant for PUNCTUAL OCCLUDER?

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

What is the FDA product code for PUNCTUAL OCCLUDER?

The FDA product code for PUNCTUAL OCCLUDER is LZU.

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 Odyssey 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.

K090938FLOW CONTROLLERK042977LASIK EYE DRAPEK972523PUNCTUAL OCCLUDER

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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