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FDA 510(k)

OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}

K-Number: K950569 · 1995-03-14

ApplicantG.W.B. Intl., Ltd.
Decision Date1995-03-14
Product CodeLZU
DecisionSubstantially Equivalent

Device Summary

OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)} 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 1995-03-14 under 510(k) number K950569. The device is classified under product code LZU. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}?

OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)} is a medical device that received FDA 510(k) clearance on 1995-03-14. The listed applicant is G.W.B. Intl., Ltd.. The 510(k) number is K950569.

When did OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)} receive FDA 510(k) clearance?

OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)} received FDA 510(k) clearance on 1995-03-14, under 510(k) number K950569.

Who is the listed applicant for OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}?

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 {SELF-THREADING MONOKA (RITLENG TYPE)}?

The FDA product code for OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)} is LZU.

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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 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.)K954094OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)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.

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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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