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FDA 510(k)

MB 105 MILLENNIUM BLADES

K-Number: K041110 · 2004-10-13

ApplicantMillennium Biomedical, Inc.
Decision Date2004-10-13
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MB 105 MILLENNIUM BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Millennium Biomedical, Inc.. It received FDA 510(k) clearance on 2004-10-13 under 510(k) number K041110. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MB 105 MILLENNIUM BLADES?

MB 105 MILLENNIUM BLADES is a medical device that received FDA 510(k) clearance on 2004-10-13. The listed applicant is Millennium Biomedical, Inc.. The 510(k) number is K041110.

When did MB 105 MILLENNIUM BLADES receive FDA 510(k) clearance?

MB 105 MILLENNIUM BLADES received FDA 510(k) clearance on 2004-10-13, under 510(k) number K041110.

Who is the listed applicant for MB 105 MILLENNIUM BLADES?

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

What is the FDA product code for MB 105 MILLENNIUM BLADES?

The FDA product code for MB 105 MILLENNIUM BLADES is HNO.

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 Millennium Biomedical, Inc. 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.

K020122MB 102 MILLENNIUM BLADESK011833MB 103 MILLENNIUM BLADESK003143MILLENNIUM BLADES, MODEL MB101K001806REFRACTIVE SURGERY BLADES

Related Devices (Code: HNO)

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.

K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.K172994EPI K ConsoleMoria SAK072102EPIVISION SL SYSTEMGebauer Medizintechnik GmbHK082043CARRIAZO-PENDULAR MICROKERATOMESchwind Eye-Tech-Solutions GmbH & Co. KGK062465ZYOPTIX XP EPI SEPARATOR SYSTEMBausch & Lomb, Inc.K052891HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEMHawken Industries

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.

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