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FDA 510(k)

DISPOSABLE N-PE MICKROKERATOME BLADES

K-Number: K032297 · 2003-08-26

ApplicantOasis Medical, Inc.
Decision Date2003-08-26
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE N-PE MICKROKERATOME BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Oasis Medical, Inc.. It received FDA 510(k) clearance on 2003-08-26 under 510(k) number K032297. 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 N-PE MICKROKERATOME BLADES?

DISPOSABLE N-PE MICKROKERATOME BLADES is a medical device that received FDA 510(k) clearance on 2003-08-26. The listed applicant is Oasis Medical, Inc.. The 510(k) number is K032297.

When did DISPOSABLE N-PE MICKROKERATOME BLADES receive FDA 510(k) clearance?

DISPOSABLE N-PE MICKROKERATOME BLADES received FDA 510(k) clearance on 2003-08-26, under 510(k) number K032297.

Who is the listed applicant for DISPOSABLE N-PE MICKROKERATOME BLADES?

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

What is the FDA product code for DISPOSABLE N-PE MICKROKERATOME BLADES?

The FDA product code for DISPOSABLE N-PE MICKROKERATOME BLADES is HNO.

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Other records listing Oasis Medical, Inc. as applicant

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Related Devices (Code: HNO)

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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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