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FDA 510(k)

FOUNDATION HYBRID COMPOSITE

K-Number: K904135 · 1991-05-15

ApplicantNulite Systems Research
Decision Date1991-05-15
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FOUNDATION HYBRID COMPOSITE is the device name listed in this FDA 510(k) record. The listed applicant is Nulite Systems Research. It received FDA 510(k) clearance on 1991-05-15 under 510(k) number K904135. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOUNDATION HYBRID COMPOSITE?

FOUNDATION HYBRID COMPOSITE is a medical device that received FDA 510(k) clearance on 1991-05-15. The listed applicant is Nulite Systems Research. The 510(k) number is K904135.

When did FOUNDATION HYBRID COMPOSITE receive FDA 510(k) clearance?

FOUNDATION HYBRID COMPOSITE received FDA 510(k) clearance on 1991-05-15, under 510(k) number K904135.

Who is the listed applicant for FOUNDATION HYBRID COMPOSITE?

The FDA 510(k) record lists Nulite Systems Research as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOUNDATION HYBRID COMPOSITE?

The FDA product code for FOUNDATION HYBRID COMPOSITE is EBD.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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