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FDA 510(k)

CCI CORNEAL SCARIFIER

K-Number: K904505 · 1991-04-23

ApplicantBuckman Co., Inc.
Decision Date1991-04-23
Product CodeGDX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CCI CORNEAL SCARIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Buckman Co., Inc.. It received FDA 510(k) clearance on 1991-04-23 under 510(k) number K904505. The device is classified under product code GDX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CCI CORNEAL SCARIFIER?

CCI CORNEAL SCARIFIER is a medical device that received FDA 510(k) clearance on 1991-04-23. The listed applicant is Buckman Co., Inc.. The 510(k) number is K904505.

When did CCI CORNEAL SCARIFIER receive FDA 510(k) clearance?

CCI CORNEAL SCARIFIER received FDA 510(k) clearance on 1991-04-23, under 510(k) number K904505.

Who is the listed applicant for CCI CORNEAL SCARIFIER?

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

What is the FDA product code for CCI CORNEAL SCARIFIER?

The FDA product code for CCI CORNEAL SCARIFIER is GDX.

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Other records listing Buckman Co., Inc. as applicant

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Related Devices (Code: GDX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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