FDA 510(k)

MILLENIUM MICROKERATOME, MODEL IMD-001

K-Number: K992687 · 1999-09-24

ApplicantIndustrial & Medical Design, Inc.

Decision Date1999-09-24

Product CodeHMY

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

MILLENIUM MICROKERATOME, MODEL IMD-001 is the device name listed in this FDA 510(k) record. The listed applicant is Industrial & Medical Design, Inc.. It received FDA 510(k) clearance on 1999-09-24 under 510(k) number K992687. The device is classified under product code HMY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MILLENIUM MICROKERATOME, MODEL IMD-001?

MILLENIUM MICROKERATOME, MODEL IMD-001 is a medical device that received FDA 510(k) clearance on 1999-09-24. The listed applicant is Industrial & Medical Design, Inc.. The 510(k) number is K992687.

When did MILLENIUM MICROKERATOME, MODEL IMD-001 receive FDA 510(k) clearance?

MILLENIUM MICROKERATOME, MODEL IMD-001 received FDA 510(k) clearance on 1999-09-24, under 510(k) number K992687.

Who is the listed applicant for MILLENIUM MICROKERATOME, MODEL IMD-001?

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

What is the FDA product code for MILLENIUM MICROKERATOME, MODEL IMD-001?

The FDA product code for MILLENIUM MICROKERATOME, MODEL IMD-001 is HMY.

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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.