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FDA 510(k)

HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01

K-Number: K994023 · 2000-04-25

ApplicantHaemacure Corp.
Decision Date2000-04-25
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01 is the device name listed in this FDA 510(k) record. The listed applicant is Haemacure Corp.. It received FDA 510(k) clearance on 2000-04-25 under 510(k) number K994023. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01?

HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01 is a medical device that received FDA 510(k) clearance on 2000-04-25. The listed applicant is Haemacure Corp.. The 510(k) number is K994023.

When did HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01 receive FDA 510(k) clearance?

HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01 received FDA 510(k) clearance on 2000-04-25, under 510(k) number K994023.

Who is the listed applicant for HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01?

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

What is the FDA product code for HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01?

The FDA product code for HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01 is FMF.

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 Haemacure Corp. 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.

K041504HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01

Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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.

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