Disposable H-Pe Microkeratome Blades

FDA 510(k) K001464 · Oasis

Substantially Equivalent

510(k) numberK001464

Submission

Device name
Disposable H-Pe Microkeratome Blades
Applicant
Oasis
Glendora, CA, US
Received
May 10, 2000
Decision date
October 2, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HNO – Keratome, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 886.4370
Specialty
Ophthalmic

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Questions and answers

When was Disposable H-Pe Microkeratome Blades cleared by the FDA?

Disposable H-Pe Microkeratome Blades (K001464) received a 510(k) decision of Substantially Equivalent on October 2, 2000, 145 days after the submission was received.

What is the product code of K001464?

The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.