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FDA 510(k)

OPHTHALMIC SPONGES

K-Number: K920354 · 1992-08-05

ApplicantUltracell Medical Technologies, Inc.
Decision Date1992-08-05
Product CodeHOZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is Ultracell Medical Technologies, Inc.. It received FDA 510(k) clearance on 1992-08-05 under 510(k) number K920354. 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 OPHTHALMIC SPONGES?

OPHTHALMIC SPONGES is a medical device that received FDA 510(k) clearance on 1992-08-05. The listed applicant is Ultracell Medical Technologies, Inc.. The 510(k) number is K920354.

When did OPHTHALMIC SPONGES receive FDA 510(k) clearance?

OPHTHALMIC SPONGES received FDA 510(k) clearance on 1992-08-05, under 510(k) number K920354.

Who is the listed applicant for OPHTHALMIC SPONGES?

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

What is the FDA product code for OPHTHALMIC SPONGES?

The FDA product code for OPHTHALMIC SPONGES is HOZ.

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Other records listing Ultracell Medical Technologies, 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.

K012196ULTRACELL ABSORBENT STICKK972634ULTRACELL SUCTION SPONGEK972633ULTRACELL SUCTION SPONGEK973083ULTRACELL NEURO SPONGESK973558VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)K973085ULTRACELL PACKING WITH SLEEVE

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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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