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FDA 510(k)

VANGUARD REPROCESSED PHACOEMULSIFICATION

K-Number: K012698 · 2001-11-09

ApplicantVanguard Medical Concepts, Inc.
Decision Date2001-11-09
Product CodeNKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VANGUARD REPROCESSED PHACOEMULSIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Vanguard Medical Concepts, Inc.. It received FDA 510(k) clearance on 2001-11-09 under 510(k) number K012698. The device is classified under product code NKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VANGUARD REPROCESSED PHACOEMULSIFICATION?

VANGUARD REPROCESSED PHACOEMULSIFICATION is a medical device that received FDA 510(k) clearance on 2001-11-09. The listed applicant is Vanguard Medical Concepts, Inc.. The 510(k) number is K012698.

When did VANGUARD REPROCESSED PHACOEMULSIFICATION receive FDA 510(k) clearance?

VANGUARD REPROCESSED PHACOEMULSIFICATION received FDA 510(k) clearance on 2001-11-09, under 510(k) number K012698.

Who is the listed applicant for VANGUARD REPROCESSED PHACOEMULSIFICATION?

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

What is the FDA product code for VANGUARD REPROCESSED PHACOEMULSIFICATION?

The FDA product code for VANGUARD REPROCESSED PHACOEMULSIFICATION is NKX.

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Other records listing Vanguard Medical Concepts, 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: NKX)

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.

K060648REPROCESSED PHACOEMULSIFICATION TIPSAlliance Medical Corp.K050518REPROCESSED PHACOEMUISIFICATION TIPSAlliance Medical, Inc.K030179MEDISISS PHACOEMULSIFICATION TIPS/NEEDLESSurgical Instruments Service and Savings, Inc.K012579REPROCESSED PHACO TIPSSterilmed, Inc.

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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