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FDA 510(k)

KOMET XK-95 PERFORATOR MOTOR (MI-102)

K-Number: K991625 · 1999-07-30

ApplicantKomet Medical
Decision Date1999-07-30
Product CodeHBB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KOMET XK-95 PERFORATOR MOTOR (MI-102) is the device name listed in this FDA 510(k) record. The listed applicant is Komet Medical. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K991625. The device is classified under product code HBB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOMET XK-95 PERFORATOR MOTOR (MI-102)?

KOMET XK-95 PERFORATOR MOTOR (MI-102) is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is Komet Medical. The 510(k) number is K991625.

When did KOMET XK-95 PERFORATOR MOTOR (MI-102) receive FDA 510(k) clearance?

KOMET XK-95 PERFORATOR MOTOR (MI-102) received FDA 510(k) clearance on 1999-07-30, under 510(k) number K991625.

Who is the listed applicant for KOMET XK-95 PERFORATOR MOTOR (MI-102)?

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

What is the FDA product code for KOMET XK-95 PERFORATOR MOTOR (MI-102)?

The FDA product code for KOMET XK-95 PERFORATOR MOTOR (MI-102) is HBB.

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 Komet Medical 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.

K984035XK-95 HIGH SPEED MOTOR DRILL SYSTEMK943758SURGICAL BUR

Related Devices (Code: HBB)

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.

K253772Velocity Alpha MR High Speed Surgical Drill SystemAdeor Medical AGK172907ELAN 4 Air Motor SystemAesculap, Inc.K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System AccessoriesMedtronic Powered Surgical SolutionsK101168LEGEND POWER ADAPTER MODEL: 6475000Medtronic Sofamor DanekK093361SYNTHES AIR PEN DRIVE (APD) SYSTEMSynthes (Usa)K090112MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700Medtronic Powered Surgical Solutions

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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