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FDA 510(k)

AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE

K-Number: K031394 · 2003-07-25

ApplicantAmerican Syringe Company
Decision Date2003-07-25
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is American Syringe Company. It received FDA 510(k) clearance on 2003-07-25 under 510(k) number K031394. 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 AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE?

AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE is a medical device that received FDA 510(k) clearance on 2003-07-25. The listed applicant is American Syringe Company. The 510(k) number is K031394.

When did AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE receive FDA 510(k) clearance?

AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE received FDA 510(k) clearance on 2003-07-25, under 510(k) number K031394.

Who is the listed applicant for AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE?

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

What is the FDA product code for AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE?

The FDA product code for AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE 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

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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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