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FDA 510(k)

SUNTOUCH EYE SPEAR

K-Number: K132796 · 2013-10-30

ApplicantHuizhou Foryou Medical Devices Co., Ltd.
Decision Date2013-10-30
Product CodeHOZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUNTOUCH EYE SPEAR is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2013-10-30 under 510(k) number K132796. 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 SUNTOUCH EYE SPEAR?

SUNTOUCH EYE SPEAR is a medical device that received FDA 510(k) clearance on 2013-10-30. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K132796.

When did SUNTOUCH EYE SPEAR receive FDA 510(k) clearance?

SUNTOUCH EYE SPEAR received FDA 510(k) clearance on 2013-10-30, under 510(k) number K132796.

Who is the listed applicant for SUNTOUCH EYE SPEAR?

The FDA 510(k) record lists Huizhou Foryou Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNTOUCH EYE SPEAR?

The FDA product code for SUNTOUCH EYE SPEAR is HOZ.

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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.

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.K003842PRESCOTT'S SURGICAL SPEARPrescott'S, 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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