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FDA 510(k)

HYDROBRUSH (TM) KERATOME

K-Number: K971078 · 1998-01-23

ApplicantMedjet, Inc.
Decision Date1998-01-23
Product CodeHQS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HYDROBRUSH (TM) KERATOME is the device name listed in this FDA 510(k) record. The listed applicant is Medjet, Inc.. It received FDA 510(k) clearance on 1998-01-23 under 510(k) number K971078. The device is classified under product code HQS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROBRUSH (TM) KERATOME?

HYDROBRUSH (TM) KERATOME is a medical device that received FDA 510(k) clearance on 1998-01-23. The listed applicant is Medjet, Inc.. The 510(k) number is K971078.

When did HYDROBRUSH (TM) KERATOME receive FDA 510(k) clearance?

HYDROBRUSH (TM) KERATOME received FDA 510(k) clearance on 1998-01-23, under 510(k) number K971078.

Who is the listed applicant for HYDROBRUSH (TM) KERATOME?

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

What is the FDA product code for HYDROBRUSH (TM) KERATOME?

The FDA product code for HYDROBRUSH (TM) KERATOME is HQS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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