FDA 510(k)

IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK

K-Number: K971832 · 1997-07-31

ApplicantM-Pact Worldwide Management Corp.

Decision Date1997-07-31

Product CodeHOZ

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK is the device name listed in this FDA 510(k) record. The listed applicant is M-Pact Worldwide Management Corp.. It received FDA 510(k) clearance on 1997-07-31 under 510(k) number K971832. 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 IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK?

IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK is a medical device that received FDA 510(k) clearance on 1997-07-31. The listed applicant is M-Pact Worldwide Management Corp.. The 510(k) number is K971832.

When did IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK receive FDA 510(k) clearance?

IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK received FDA 510(k) clearance on 1997-07-31, under 510(k) number K971832.

Who is the listed applicant for IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK?

The FDA 510(k) record lists M-Pact Worldwide Management Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK?

The FDA product code for IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK is HOZ.

Related Clinical Trials

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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Other records listing M-Pact Worldwide Management Corp. as applicant

K971473IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK K964113IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL

Related Devices (Code: HOZ)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.