FDA 510(k)

BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD

K-Number: K001902 · 2000-07-10

Decision Date2000-07-10

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Ent LLC. It received FDA 510(k) clearance on 2000-07-10 under 510(k) number K001902. The device is classified under product code ETA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD?

BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD is a medical device that received FDA 510(k) clearance on 2000-07-10. The listed applicant is Gyrus Ent LLC. The 510(k) number is K001902.

When did BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD receive FDA 510(k) clearance?

BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD received FDA 510(k) clearance on 2000-07-10, under 510(k) number K001902.

Who is the listed applicant for BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD?

The FDA 510(k) record lists Gyrus Ent LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD?

The FDA product code for BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD is ETA.

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Related Devices (Code: ETA)

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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.