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FDA 510(k)

CENEFOM PVA SURGICAL SPEAR

K-Number: K082460 · 2008-12-15

ApplicantLongtek Scientific Co., Ltd.
Decision Date2008-12-15
Product CodeHOZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CENEFOM PVA SURGICAL SPEAR is the device name listed in this FDA 510(k) record. The listed applicant is Longtek Scientific Co., Ltd.. It received FDA 510(k) clearance on 2008-12-15 under 510(k) number K082460. 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 CENEFOM PVA SURGICAL SPEAR?

CENEFOM PVA SURGICAL SPEAR is a medical device that received FDA 510(k) clearance on 2008-12-15. The listed applicant is Longtek Scientific Co., Ltd.. The 510(k) number is K082460.

When did CENEFOM PVA SURGICAL SPEAR receive FDA 510(k) clearance?

CENEFOM PVA SURGICAL SPEAR received FDA 510(k) clearance on 2008-12-15, under 510(k) number K082460.

Who is the listed applicant for CENEFOM PVA SURGICAL SPEAR?

The FDA 510(k) record lists Longtek Scientific Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENEFOM PVA SURGICAL SPEAR?

The FDA product code for CENEFOM PVA SURGICAL 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.

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.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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