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FDA 510(k)

UNIMAX SUCTION IRRIGATION SET

K-Number: K103509 · 2011-05-19

ApplicantUnimax Medical Systems, Inc.
Decision Date2011-05-19
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UNIMAX SUCTION IRRIGATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Unimax Medical Systems, Inc.. It received FDA 510(k) clearance on 2011-05-19 under 510(k) number K103509. 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 UNIMAX SUCTION IRRIGATION SET?

UNIMAX SUCTION IRRIGATION SET is a medical device that received FDA 510(k) clearance on 2011-05-19. The listed applicant is Unimax Medical Systems, Inc.. The 510(k) number is K103509.

When did UNIMAX SUCTION IRRIGATION SET receive FDA 510(k) clearance?

UNIMAX SUCTION IRRIGATION SET received FDA 510(k) clearance on 2011-05-19, under 510(k) number K103509.

Who is the listed applicant for UNIMAX SUCTION IRRIGATION SET?

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

What is the FDA product code for UNIMAX SUCTION IRRIGATION SET?

The FDA product code for UNIMAX SUCTION IRRIGATION SET is GCJ.

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Other records listing Unimax Medical Systems, Inc. as applicant

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Related Devices (Code: 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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