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FDA 510(k)

AUTOMATIC CORNEAL SHAPER

K-Number: K913697 · 1991-11-05

ApplicantHansa Research & Development, Inc.
Decision Date1991-11-05
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AUTOMATIC CORNEAL SHAPER is the device name listed in this FDA 510(k) record. The listed applicant is Hansa Research & Development, Inc.. It received FDA 510(k) clearance on 1991-11-05 under 510(k) number K913697. 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 AUTOMATIC CORNEAL SHAPER?

AUTOMATIC CORNEAL SHAPER is a medical device that received FDA 510(k) clearance on 1991-11-05. The listed applicant is Hansa Research & Development, Inc.. The 510(k) number is K913697.

When did AUTOMATIC CORNEAL SHAPER receive FDA 510(k) clearance?

AUTOMATIC CORNEAL SHAPER received FDA 510(k) clearance on 1991-11-05, under 510(k) number K913697.

Who is the listed applicant for AUTOMATIC CORNEAL SHAPER?

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

What is the FDA product code for AUTOMATIC CORNEAL SHAPER?

The FDA product code for AUTOMATIC CORNEAL SHAPER is HNO.

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Related Devices (Code: HNO)

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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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