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FDA 510(k)

ESTILUX POSTERIOR XR

K-Number: K813568 · 1982-01-29

ApplicantKulzer, Inc.
Decision Date1982-01-29
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ESTILUX POSTERIOR XR is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, Inc.. It received FDA 510(k) clearance on 1982-01-29 under 510(k) number K813568. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESTILUX POSTERIOR XR?

ESTILUX POSTERIOR XR is a medical device that received FDA 510(k) clearance on 1982-01-29. The listed applicant is Kulzer, Inc.. The 510(k) number is K813568.

When did ESTILUX POSTERIOR XR receive FDA 510(k) clearance?

ESTILUX POSTERIOR XR received FDA 510(k) clearance on 1982-01-29, under 510(k) number K813568.

Who is the listed applicant for ESTILUX POSTERIOR XR?

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

What is the FDA product code for ESTILUX POSTERIOR XR?

The FDA product code for ESTILUX POSTERIOR XR is EBF.

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Related Devices (Code: EBF)

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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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