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FDA 510(k)

SUCTION/IRRIGATION PROBE

K-Number: K914782 · 1991-12-09

ApplicantO.R. Concepts, Inc.
Decision Date1991-12-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUCTION/IRRIGATION PROBE 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 1991-12-09 under 510(k) number K914782. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUCTION/IRRIGATION PROBE?

SUCTION/IRRIGATION PROBE is a medical device that received FDA 510(k) clearance on 1991-12-09. The listed applicant is O.R. Concepts, Inc.. The 510(k) number is K914782.

When did SUCTION/IRRIGATION PROBE receive FDA 510(k) clearance?

SUCTION/IRRIGATION PROBE received FDA 510(k) clearance on 1991-12-09, under 510(k) number K914782.

Who is the listed applicant for SUCTION/IRRIGATION PROBE?

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 SUCTION/IRRIGATION PROBE?

The FDA product code for SUCTION/IRRIGATION PROBE is GCJ.

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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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