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FDA 510(k)

CORNEO-GAGE TWO

K-Number: K852862 · 1986-01-30

ApplicantSonogage, Inc.
Decision Date1986-01-30
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CORNEO-GAGE TWO is the device name listed in this FDA 510(k) record. The listed applicant is Sonogage, Inc.. It received FDA 510(k) clearance on 1986-01-30 under 510(k) number K852862. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORNEO-GAGE TWO?

CORNEO-GAGE TWO is a medical device that received FDA 510(k) clearance on 1986-01-30. The listed applicant is Sonogage, Inc.. The 510(k) number is K852862.

When did CORNEO-GAGE TWO receive FDA 510(k) clearance?

CORNEO-GAGE TWO received FDA 510(k) clearance on 1986-01-30, under 510(k) number K852862.

Who is the listed applicant for CORNEO-GAGE TWO?

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

What is the FDA product code for CORNEO-GAGE TWO?

The FDA product code for CORNEO-GAGE TWO is IYO.

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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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