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FDA 510(k)

ORL-E-92 SURGICAL DRILL SYSTEM

K-Number: K984244 · 1999-02-23

ApplicantBien Air USA, Inc.
Decision Date1999-02-23
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORL-E-92 SURGICAL DRILL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bien Air USA, Inc.. It received FDA 510(k) clearance on 1999-02-23 under 510(k) number K984244. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORL-E-92 SURGICAL DRILL SYSTEM?

ORL-E-92 SURGICAL DRILL SYSTEM is a medical device that received FDA 510(k) clearance on 1999-02-23. The listed applicant is Bien Air USA, Inc.. The 510(k) number is K984244.

When did ORL-E-92 SURGICAL DRILL SYSTEM receive FDA 510(k) clearance?

ORL-E-92 SURGICAL DRILL SYSTEM received FDA 510(k) clearance on 1999-02-23, under 510(k) number K984244.

Who is the listed applicant for ORL-E-92 SURGICAL DRILL SYSTEM?

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

What is the FDA product code for ORL-E-92 SURGICAL DRILL SYSTEM?

The FDA product code for ORL-E-92 SURGICAL DRILL SYSTEM is EFB.

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Other records listing Bien Air USA, Inc. as applicant

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Related Devices (Code: EFB)

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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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