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FDA 510(k)

ROYALE II

K-Number: K831095 · 1983-08-31

ApplicantFactor, Ii, Inc.
Decision Date1983-08-31
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROYALE II is the device name listed in this FDA 510(k) record. The listed applicant is Factor, Ii, Inc.. It received FDA 510(k) clearance on 1983-08-31 under 510(k) number K831095. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROYALE II?

ROYALE II is a medical device that received FDA 510(k) clearance on 1983-08-31. The listed applicant is Factor, Ii, Inc.. The 510(k) number is K831095.

When did ROYALE II receive FDA 510(k) clearance?

ROYALE II received FDA 510(k) clearance on 1983-08-31, under 510(k) number K831095.

Who is the listed applicant for ROYALE II?

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

What is the FDA product code for ROYALE II?

The FDA product code for ROYALE II is EBI.

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Other records listing Factor, Ii, Inc. 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.

K984297MAGNA ABUTMENTK880329FACTOR II PROSTHETIC SILICONE ELASTOMER

Related Devices (Code: EBI)

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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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