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FDA 510(k)

ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30

K-Number: K081545 · 2008-10-02

Decision Date2008-10-02
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Optics, Inc.. It received FDA 510(k) clearance on 2008-10-02 under 510(k) number K081545. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30?

ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 is a medical device that received FDA 510(k) clearance on 2008-10-02. The listed applicant is Advanced Medical Optics, Inc.. The 510(k) number is K081545.

When did ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 receive FDA 510(k) clearance?

ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 received FDA 510(k) clearance on 2008-10-02, under 510(k) number K081545.

Who is the listed applicant for ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30?

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

What is the FDA product code for ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30?

The FDA product code for ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 is MSS.

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.

Other records listing Advanced Medical Optics, 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.

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Related Devices (Code: MSS)

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.

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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