FDA 510(k)

TRI HAWK BUR, FG BUR

K-Number: K943273 · 1994-08-01

Decision Date1994-08-01

Product CodeEJL

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

TRI HAWK BUR, FG BUR is the device name listed in this FDA 510(k) record. The listed applicant is Tri Hawk Corp.. It received FDA 510(k) clearance on 1994-08-01 under 510(k) number K943273. The device is classified under product code EJL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI HAWK BUR, FG BUR?

TRI HAWK BUR, FG BUR is a medical device that received FDA 510(k) clearance on 1994-08-01. The listed applicant is Tri Hawk Corp.. The 510(k) number is K943273.

When did TRI HAWK BUR, FG BUR receive FDA 510(k) clearance?

TRI HAWK BUR, FG BUR received FDA 510(k) clearance on 1994-08-01, under 510(k) number K943273.

Who is the listed applicant for TRI HAWK BUR, FG BUR?

The FDA 510(k) record lists Tri Hawk Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRI HAWK BUR, FG BUR?

The FDA product code for TRI HAWK BUR, FG BUR is EJL.

Related Devices (Code: EJL)

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.

K080687SMARTBURSS.S. White Burs, Inc.K071352CERADRILLGebr. Brasseler GmbH & Co. KG K061383BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPSB.T.I. Biotechnology Institute, Sl.K926205MONOSTERYLUtensili Super Abrasivi K923883DENTAL OR SURGICAL BURStratum Dental Technologies, Inc.K921406SILICONT BUR BLOCKInnovators, Inc.

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.