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FDA 510(k)

CHAMPION, 3000 REBEL

K-Number: K953427 · 1995-07-31

ApplicantKuschall of America
Decision Date1995-07-31
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CHAMPION, 3000 REBEL is the device name listed in this FDA 510(k) record. The listed applicant is Kuschall of America. It received FDA 510(k) clearance on 1995-07-31 under 510(k) number K953427. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHAMPION, 3000 REBEL?

CHAMPION, 3000 REBEL is a medical device that received FDA 510(k) clearance on 1995-07-31. The listed applicant is Kuschall of America. The 510(k) number is K953427.

When did CHAMPION, 3000 REBEL receive FDA 510(k) clearance?

CHAMPION, 3000 REBEL received FDA 510(k) clearance on 1995-07-31, under 510(k) number K953427.

Who is the listed applicant for CHAMPION, 3000 REBEL?

The FDA 510(k) record lists Kuschall of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHAMPION, 3000 REBEL?

The FDA product code for CHAMPION, 3000 REBEL is IOR.

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.

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Other records listing Kuschall of America 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.

K953429CHAMPION, 1000K953426COMPETITORK953428CHAMPION, 3000

Related Devices (Code: IOR)

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.

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Official Source

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