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FDA 510(k)

EAGLEVISION GELLANSERTS, MODEL REF 0040

K-Number: K053333 · 2006-05-02

ApplicantEagle Vision, Inc.
Decision Date2006-05-02
Product CodeLZU
DecisionSubstantially Equivalent

Device Summary

EAGLEVISION GELLANSERTS, MODEL REF 0040 is the device name listed in this FDA 510(k) record. The listed applicant is Eagle Vision, Inc.. It received FDA 510(k) clearance on 2006-05-02 under 510(k) number K053333. The device is classified under product code LZU. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EAGLEVISION GELLANSERTS, MODEL REF 0040?

EAGLEVISION GELLANSERTS, MODEL REF 0040 is a medical device that received FDA 510(k) clearance on 2006-05-02. The listed applicant is Eagle Vision, Inc.. The 510(k) number is K053333.

When did EAGLEVISION GELLANSERTS, MODEL REF 0040 receive FDA 510(k) clearance?

EAGLEVISION GELLANSERTS, MODEL REF 0040 received FDA 510(k) clearance on 2006-05-02, under 510(k) number K053333.

Who is the listed applicant for EAGLEVISION GELLANSERTS, MODEL REF 0040?

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

What is the FDA product code for EAGLEVISION GELLANSERTS, MODEL REF 0040?

The FDA product code for EAGLEVISION GELLANSERTS, MODEL REF 0040 is LZU.

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Other records listing Eagle Vision, 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.

K030353MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETSK991130FLEXPLUGK905427EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUGK890919TEMPORARY INTRACANALICULAR COLLAGEN IMPLANTK890920EAGLE VISION-FREEMAN(TM) PUNCTAL VALVEK883233EV MONOCANALICULAR STENT (TM)

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Related Devices (Code: LZU)

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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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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