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FDA 510(k)

OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)

K-Number: K954094 · 1995-10-05

ApplicantG.W.B. Intl., Ltd.
Decision Date1995-10-05
Product CodeLZU
DecisionSubstantially Equivalent

Device Summary

OPHTA SIL- PUNCTAL PLUGS (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is G.W.B. Intl., Ltd.. It received FDA 510(k) clearance on 1995-10-05 under 510(k) number K954094. The device is classified under product code LZU. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)?

OPHTA SIL- PUNCTAL PLUGS (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1995-10-05. The listed applicant is G.W.B. Intl., Ltd.. The 510(k) number is K954094.

When did OPHTA SIL- PUNCTAL PLUGS (MODIFICATION) receive FDA 510(k) clearance?

OPHTA SIL- PUNCTAL PLUGS (MODIFICATION) received FDA 510(k) clearance on 1995-10-05, under 510(k) number K954094.

Who is the listed applicant for OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)?

The FDA 510(k) record lists G.W.B. Intl., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)?

The FDA product code for OPHTA SIL- PUNCTAL PLUGS (MODIFICATION) is LZU.

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Other records listing G.W.B. Intl., Ltd. 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.

K955671RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)K950569OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}K940508OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)K911110OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTSK911108OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERSK911109OPHTA SIL (R), LACHRYMAL INTUBATION SETS

View all 8 devices →

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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