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FDA 510(k)

SURGICAL DISPOSABLE STERILE & NONSTERIL

K-Number: K834368 · 1984-03-05

ApplicantMarbex, Inc.
Decision Date1984-03-05
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURGICAL DISPOSABLE STERILE & NONSTERIL is the device name listed in this FDA 510(k) record. The listed applicant is Marbex, Inc.. It received FDA 510(k) clearance on 1984-03-05 under 510(k) number K834368. 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 SURGICAL DISPOSABLE STERILE & NONSTERIL?

SURGICAL DISPOSABLE STERILE & NONSTERIL is a medical device that received FDA 510(k) clearance on 1984-03-05. The listed applicant is Marbex, Inc.. The 510(k) number is K834368.

When did SURGICAL DISPOSABLE STERILE & NONSTERIL receive FDA 510(k) clearance?

SURGICAL DISPOSABLE STERILE & NONSTERIL received FDA 510(k) clearance on 1984-03-05, under 510(k) number K834368.

Who is the listed applicant for SURGICAL DISPOSABLE STERILE & NONSTERIL?

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

What is the FDA product code for SURGICAL DISPOSABLE STERILE & NONSTERIL?

The FDA product code for SURGICAL DISPOSABLE STERILE & NONSTERIL is FMF.

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Other records listing Marbex, 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.

K841187BLOOD COLLECTION SET, STERILE, DISPOS.K841185PLASTIC, STERILE TUBING CLOSED SETK841186INFUSION SET SCALP VEIN

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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