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FDA 510(k)

SCMD KERATOME

K-Number: K935342 · 1994-04-01

ApplicantS.C.M.D. Keratomes of Arizona
Decision Date1994-04-01
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SCMD KERATOME is the device name listed in this FDA 510(k) record. The listed applicant is S.C.M.D. Keratomes of Arizona. It received FDA 510(k) clearance on 1994-04-01 under 510(k) number K935342. 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 SCMD KERATOME?

SCMD KERATOME is a medical device that received FDA 510(k) clearance on 1994-04-01. The listed applicant is S.C.M.D. Keratomes of Arizona. The 510(k) number is K935342.

When did SCMD KERATOME receive FDA 510(k) clearance?

SCMD KERATOME received FDA 510(k) clearance on 1994-04-01, under 510(k) number K935342.

Who is the listed applicant for SCMD KERATOME?

The FDA 510(k) record lists S.C.M.D. Keratomes of Arizona as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCMD KERATOME?

The FDA product code for SCMD KERATOME is 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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