FDA 510(k)

MOJAVE CATARACT EXTRACTION SYSTEM

K-Number: K003638 · 2001-02-13

Decision Date2001-02-13

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

MOJAVE CATARACT EXTRACTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Allergan, Inc.. It received FDA 510(k) clearance on 2001-02-13 under 510(k) number K003638. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOJAVE CATARACT EXTRACTION SYSTEM?

MOJAVE CATARACT EXTRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 2001-02-13. The listed applicant is Allergan, Inc.. The 510(k) number is K003638.

When did MOJAVE CATARACT EXTRACTION SYSTEM receive FDA 510(k) clearance?

MOJAVE CATARACT EXTRACTION SYSTEM received FDA 510(k) clearance on 2001-02-13, under 510(k) number K003638.

Who is the listed applicant for MOJAVE CATARACT EXTRACTION SYSTEM?

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

What is the FDA product code for MOJAVE CATARACT EXTRACTION SYSTEM?

The FDA product code for MOJAVE CATARACT EXTRACTION SYSTEM is HQC.

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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.