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FDA 510(k)

CONTOUR FLEX VALVES (REGULAR & SMALL)

K-Number: K954285 · 1996-01-26

ApplicantRadionics, Inc.
Decision Date1996-01-26
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CONTOUR FLEX VALVES (REGULAR & SMALL) is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1996-01-26 under 510(k) number K954285. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTOUR FLEX VALVES (REGULAR & SMALL)?

CONTOUR FLEX VALVES (REGULAR & SMALL) is a medical device that received FDA 510(k) clearance on 1996-01-26. The listed applicant is Radionics, Inc.. The 510(k) number is K954285.

When did CONTOUR FLEX VALVES (REGULAR & SMALL) receive FDA 510(k) clearance?

CONTOUR FLEX VALVES (REGULAR & SMALL) received FDA 510(k) clearance on 1996-01-26, under 510(k) number K954285.

Who is the listed applicant for CONTOUR FLEX VALVES (REGULAR & SMALL)?

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

What is the FDA product code for CONTOUR FLEX VALVES (REGULAR & SMALL)?

The FDA product code for CONTOUR FLEX VALVES (REGULAR & SMALL) is JXG.

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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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