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FDA 510(k)

ALCON SURGICAL SPONGE

K-Number: K896004 · 1989-11-02

ApplicantAlcon Laboratories
Decision Date1989-11-02
Product CodeHOZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ALCON SURGICAL SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories. It received FDA 510(k) clearance on 1989-11-02 under 510(k) number K896004. The device is classified under product code HOZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALCON SURGICAL SPONGE?

ALCON SURGICAL SPONGE is a medical device that received FDA 510(k) clearance on 1989-11-02. The listed applicant is Alcon Laboratories. The 510(k) number is K896004.

When did ALCON SURGICAL SPONGE receive FDA 510(k) clearance?

ALCON SURGICAL SPONGE received FDA 510(k) clearance on 1989-11-02, under 510(k) number K896004.

Who is the listed applicant for ALCON SURGICAL SPONGE?

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

What is the FDA product code for ALCON SURGICAL SPONGE?

The FDA product code for ALCON SURGICAL SPONGE is HOZ.

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Other records listing Alcon Laboratories as applicant

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Related Devices (Code: HOZ)

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.

K132796SUNTOUCH EYE SPEARHuizhou Foryou Medical Devices Co., Ltd.K130117NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSNetwork Medical Products, Ltd.K091240ALPHAMED SURGICAL SPEAR, MODEL 70-5000Alphamed, Inc.K082460CENEFOM PVA SURGICAL SPEARLongtek Scientific Co., Ltd.K012196ULTRACELL ABSORBENT STICKUltracell Medical Technologies, Inc.K011191MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGESMedtronic Xomed, 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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