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FDA 510(k)

SOVEREIGN CATARACT EXTRACTION SYSTEM

K-Number: K981116 · 1998-05-19

ApplicantAllergan, Inc.
Decision Date1998-05-19
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SOVEREIGN 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 1998-05-19 under 510(k) number K981116. The device is classified under product code KYG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOVEREIGN CATARACT EXTRACTION SYSTEM?

SOVEREIGN CATARACT EXTRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-19. The listed applicant is Allergan, Inc.. The 510(k) number is K981116.

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

SOVEREIGN CATARACT EXTRACTION SYSTEM received FDA 510(k) clearance on 1998-05-19, under 510(k) number K981116.

Who is the listed applicant for SOVEREIGN 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 SOVEREIGN CATARACT EXTRACTION SYSTEM?

The FDA product code for SOVEREIGN CATARACT EXTRACTION SYSTEM is KYG.

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Related Devices (Code: KYG)

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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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