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FDA 510(k)

SCLERAL PLUGS, 19 AND 20 GAUGE

K-Number: K990872 · 1999-07-13

ApplicantOphthalmic Consultants, Inc.
Decision Date1999-07-13
Product CodeLXP
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SCLERAL PLUGS, 19 AND 20 GAUGE is the device name listed in this FDA 510(k) record. The listed applicant is Ophthalmic Consultants, Inc.. It received FDA 510(k) clearance on 1999-07-13 under 510(k) number K990872. The device is classified under product code LXP. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCLERAL PLUGS, 19 AND 20 GAUGE?

SCLERAL PLUGS, 19 AND 20 GAUGE is a medical device that received FDA 510(k) clearance on 1999-07-13. The listed applicant is Ophthalmic Consultants, Inc.. The 510(k) number is K990872.

When did SCLERAL PLUGS, 19 AND 20 GAUGE receive FDA 510(k) clearance?

SCLERAL PLUGS, 19 AND 20 GAUGE received FDA 510(k) clearance on 1999-07-13, under 510(k) number K990872.

Who is the listed applicant for SCLERAL PLUGS, 19 AND 20 GAUGE?

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

What is the FDA product code for SCLERAL PLUGS, 19 AND 20 GAUGE?

The FDA product code for SCLERAL PLUGS, 19 AND 20 GAUGE is LXP.

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 Ophthalmic Consultants, 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.

K990292I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN

Related Devices (Code: LXP)

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.

K022186SCLERAL PLUGS, 19 AND 20 GAUGEMicrovision, Inc.K945114VISITEC SCLERAL PLUGVisitec Co.K925671DISPOSABLE SCLERAL PLUGSO.R. Specialties, Inc.K880953ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUGAdvanced Surgical Products, Inc.K880952PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGSAdvanced Surgical Products, Inc.K871604MVS 19 AND MVS 20 GAUGE SCLERAL PLUGSAdvanced Surgical Products, 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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