Cleared Traditional

DISPOSABLE CB-PE MICROKERATOME BLADES

K003820 · Oasis Medical, Inc. · Ophthalmic
Mar 2001
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K003820 is an FDA 510(k) clearance for the DISPOSABLE CB-PE MICROKERATOME BLADES, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on March 8, 2001, 87 days after receiving the submission on December 11, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K003820 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2000
Decision Date March 08, 2001
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HNO — Keratome, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4370

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