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FDA 510(k)

THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910

K-Number: K071826 · 2007-11-09

Decision Date2007-11-09
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 is the device name listed in this FDA 510(k) record. The listed applicant is Fox Hollow Technologies. It received FDA 510(k) clearance on 2007-11-09 under 510(k) number K071826. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910?

THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 is a medical device that received FDA 510(k) clearance on 2007-11-09. The listed applicant is Fox Hollow Technologies. The 510(k) number is K071826.

When did THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 receive FDA 510(k) clearance?

THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 received FDA 510(k) clearance on 2007-11-09, under 510(k) number K071826.

Who is the listed applicant for THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910?

The FDA 510(k) record lists Fox Hollow Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910?

The FDA product code for THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 is QEZ.

Related Clinical Trials

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.

Other records listing Fox Hollow Technologies as applicant

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.

Related Devices (Code: QEZ)

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.

Official Source

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