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FDA 510(k)

SMALL HIGH SPEED MOTOR DRILL SYSTEM

K-Number: K030172 · 2003-04-03

ApplicantBrasseler USA I, L.P.
Decision Date2003-04-03
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SMALL HIGH SPEED MOTOR DRILL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Brasseler USA I, L.P.. It received FDA 510(k) clearance on 2003-04-03 under 510(k) number K030172. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMALL HIGH SPEED MOTOR DRILL SYSTEM?

SMALL HIGH SPEED MOTOR DRILL SYSTEM is a medical device that received FDA 510(k) clearance on 2003-04-03. The listed applicant is Brasseler USA I, L.P.. The 510(k) number is K030172.

When did SMALL HIGH SPEED MOTOR DRILL SYSTEM receive FDA 510(k) clearance?

SMALL HIGH SPEED MOTOR DRILL SYSTEM received FDA 510(k) clearance on 2003-04-03, under 510(k) number K030172.

Who is the listed applicant for SMALL HIGH SPEED MOTOR DRILL SYSTEM?

The FDA 510(k) record lists Brasseler USA I, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMALL HIGH SPEED MOTOR DRILL SYSTEM?

The FDA product code for SMALL HIGH SPEED MOTOR DRILL SYSTEM is HBE.

Related Clinical Trials

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.

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Other records listing Brasseler USA I, L.P. 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.

K983223DENTAL STERLIZATION TRAY/CASSETTEK9551402.0 X 6MM SCREWK945670KIRSCHNER (K-WIRE), STEINMAN PINS

Related Devices (Code: HBE)

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.

K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)Surgify Medical OYK250815Hubly Drill (H100)Hubly, Inc.K252060GREENPhasor Health, LLCK252662UniBurNakanishi, Inc.K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)Surgify Medical OYK250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)Surgify Medical OY

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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