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FDA 510(k)

DISPOSABLE H-PE MICROKERATOME BLADES

K-Number: K001464 · 2000-10-02

ApplicantOasis
Decision Date2000-10-02
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE H-PE MICROKERATOME BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Oasis. It received FDA 510(k) clearance on 2000-10-02 under 510(k) number K001464. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE H-PE MICROKERATOME BLADES?

DISPOSABLE H-PE MICROKERATOME BLADES is a medical device that received FDA 510(k) clearance on 2000-10-02. The listed applicant is Oasis. The 510(k) number is K001464.

When did DISPOSABLE H-PE MICROKERATOME BLADES receive FDA 510(k) clearance?

DISPOSABLE H-PE MICROKERATOME BLADES received FDA 510(k) clearance on 2000-10-02, under 510(k) number K001464.

Who is the listed applicant for DISPOSABLE H-PE MICROKERATOME BLADES?

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

What is the FDA product code for DISPOSABLE H-PE MICROKERATOME BLADES?

The FDA product code for DISPOSABLE H-PE MICROKERATOME BLADES is HNO.

Related Clinical Trials

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Other records listing Oasis 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.

K954449ENT PACKINGS, WICKS, WIPES, AND SPONGES

Related Devices (Code: HNO)

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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