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FDA 510(k)

O.R. CONCEPTS' IRRIGATING KITTNER

K-Number: K923818 · 1993-04-07

ApplicantO.R. Concepts, Inc.
Decision Date1993-04-07
Product CodeFGS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

O.R. CONCEPTS' IRRIGATING KITTNER is the device name listed in this FDA 510(k) record. The listed applicant is O.R. Concepts, Inc.. It received FDA 510(k) clearance on 1993-04-07 under 510(k) number K923818. The device is classified under product code FGS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O.R. CONCEPTS' IRRIGATING KITTNER?

O.R. CONCEPTS' IRRIGATING KITTNER is a medical device that received FDA 510(k) clearance on 1993-04-07. The listed applicant is O.R. Concepts, Inc.. The 510(k) number is K923818.

When did O.R. CONCEPTS' IRRIGATING KITTNER receive FDA 510(k) clearance?

O.R. CONCEPTS' IRRIGATING KITTNER received FDA 510(k) clearance on 1993-04-07, under 510(k) number K923818.

Who is the listed applicant for O.R. CONCEPTS' IRRIGATING KITTNER?

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

What is the FDA product code for O.R. CONCEPTS' IRRIGATING KITTNER?

The FDA product code for O.R. CONCEPTS' IRRIGATING KITTNER is FGS.

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Other records listing O.R. Concepts, Inc. as applicant

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Related Devices (Code: FGS)

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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