Millennium Blades, Model MB101

FDA 510(k) K003143 · Millennium Biomedical, Inc.

Substantially Equivalent

510(k) numberK003143

Submission

Device name
Millennium Blades, Model MB101
Applicant
Millennium Biomedical, Inc.
Pomona, CA, US
Received
October 10, 2000
Decision date
December 11, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HNO – Keratome, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 886.4370
Specialty
Ophthalmic

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K043183Epi-KHNO · Traditional Moria SA03/25/2005SE
K043150Amadeus II EpikeratomeHNO · Special Sis Ltd., Surgical Instrument Systems01/31/2005SE
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More from Biovision AG

510(k)DeviceDecision
K041110MB 105 Millennium BladesHNO · Traditional 10/13/2004SE
K020122MB 102 Millennium BladesHNO · Traditional 02/15/2002SE
K011833MB 103 Millennium BladesHNO · Traditional 02/15/2002SE
K001806Refractive Surgery BladesHNO · Traditional 09/12/2000SE

Questions and answers

When was Millennium Blades, Model MB101 cleared by the FDA?

Millennium Blades, Model MB101 (K003143) received a 510(k) decision of Substantially Equivalent on December 11, 2000, 62 days after the submission was received.

What is the product code of K003143?

The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.