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FDA 510(k)

DUPLOGRIP

K-Number: K003193 · 2000-11-07

ApplicantBaxter Healthcare Corp
Decision Date2000-11-07
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DUPLOGRIP is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 2000-11-07 under 510(k) number K003193. 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 DUPLOGRIP?

DUPLOGRIP is a medical device that received FDA 510(k) clearance on 2000-11-07. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K003193.

When did DUPLOGRIP receive FDA 510(k) clearance?

DUPLOGRIP received FDA 510(k) clearance on 2000-11-07, under 510(k) number K003193.

Who is the listed applicant for DUPLOGRIP?

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

What is the FDA product code for DUPLOGRIP?

The FDA product code for DUPLOGRIP is FMF.

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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

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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