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FDA 510(k)

DISPOSABLE ASPIRATION IRRIGATION SYSTEM

K-Number: K912093 · 1992-04-24

ApplicantApplied Urology, Inc.
Decision Date1992-04-24
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ASPIRATION IRRIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Applied Urology, Inc.. It received FDA 510(k) clearance on 1992-04-24 under 510(k) number K912093. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE ASPIRATION IRRIGATION SYSTEM?

DISPOSABLE ASPIRATION IRRIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 1992-04-24. The listed applicant is Applied Urology, Inc.. The 510(k) number is K912093.

When did DISPOSABLE ASPIRATION IRRIGATION SYSTEM receive FDA 510(k) clearance?

DISPOSABLE ASPIRATION IRRIGATION SYSTEM received FDA 510(k) clearance on 1992-04-24, under 510(k) number K912093.

Who is the listed applicant for DISPOSABLE ASPIRATION IRRIGATION SYSTEM?

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

What is the FDA product code for DISPOSABLE ASPIRATION IRRIGATION SYSTEM?

The FDA product code for DISPOSABLE ASPIRATION IRRIGATION SYSTEM is HET.

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Other records listing Applied Urology, Inc. as applicant

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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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