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FDA 510(k)

HANSATOME MICROKERATOME

K-Number: K972808 · 1997-10-24

ApplicantChiron Vision Corp.
Decision Date1997-10-24
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HANSATOME MICROKERATOME is the device name listed in this FDA 510(k) record. The listed applicant is Chiron Vision Corp.. It received FDA 510(k) clearance on 1997-10-24 under 510(k) number K972808. 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 HANSATOME MICROKERATOME?

HANSATOME MICROKERATOME is a medical device that received FDA 510(k) clearance on 1997-10-24. The listed applicant is Chiron Vision Corp.. The 510(k) number is K972808.

When did HANSATOME MICROKERATOME receive FDA 510(k) clearance?

HANSATOME MICROKERATOME received FDA 510(k) clearance on 1997-10-24, under 510(k) number K972808.

Who is the listed applicant for HANSATOME MICROKERATOME?

The FDA 510(k) record lists Chiron Vision Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HANSATOME MICROKERATOME?

The FDA product code for HANSATOME MICROKERATOME is 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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