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FDA 510(k)

DISPOSABLE SCLERAL PLUGS

K-Number: K925671 · 1993-08-02

ApplicantO.R. Specialties, Inc.
Decision Date1993-08-02
Product CodeLXP
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SCLERAL PLUGS is the device name listed in this FDA 510(k) record. The listed applicant is O.R. Specialties, Inc.. It received FDA 510(k) clearance on 1993-08-02 under 510(k) number K925671. 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 DISPOSABLE SCLERAL PLUGS?

DISPOSABLE SCLERAL PLUGS is a medical device that received FDA 510(k) clearance on 1993-08-02. The listed applicant is O.R. Specialties, Inc.. The 510(k) number is K925671.

When did DISPOSABLE SCLERAL PLUGS receive FDA 510(k) clearance?

DISPOSABLE SCLERAL PLUGS received FDA 510(k) clearance on 1993-08-02, under 510(k) number K925671.

Who is the listed applicant for DISPOSABLE SCLERAL PLUGS?

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

What is the FDA product code for DISPOSABLE SCLERAL PLUGS?

The FDA product code for DISPOSABLE SCLERAL PLUGS is LXP.

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Other records listing O.R. Specialties, 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.

K942607LAPAROSCOPIC SCISSORS (DISPOSABLE)K923630PHACO NEEDLES 1000-R & 1000-O NEEDLESK923887JACK'S VENT TUBESK923774DISPOSABLE ENDOILLUMINATORK922355POLLY'S VITREOUS SCISSORS J-225-SK922180LEWICKY O.R.S. TUBING

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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.K990872SCLERAL PLUGS, 19 AND 20 GAUGEOphthalmic Consultants, Inc.K945114VISITEC SCLERAL PLUGVisitec Co.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

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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