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FDA 510(k)

CAREJECT DISPOSABLE SYRINGE AND NEEDLE

K-Number: K931472 · 1994-02-22

ApplicantCarewell Mediproducts, Ltd.
Decision Date1994-02-22
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CAREJECT DISPOSABLE SYRINGE AND NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Carewell Mediproducts, Ltd.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K931472. 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 CAREJECT DISPOSABLE SYRINGE AND NEEDLE?

CAREJECT DISPOSABLE SYRINGE AND NEEDLE is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Carewell Mediproducts, Ltd.. The 510(k) number is K931472.

When did CAREJECT DISPOSABLE SYRINGE AND NEEDLE receive FDA 510(k) clearance?

CAREJECT DISPOSABLE SYRINGE AND NEEDLE received FDA 510(k) clearance on 1994-02-22, under 510(k) number K931472.

Who is the listed applicant for CAREJECT DISPOSABLE SYRINGE AND NEEDLE?

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

What is the FDA product code for CAREJECT DISPOSABLE SYRINGE AND NEEDLE?

The FDA product code for CAREJECT DISPOSABLE SYRINGE AND NEEDLE 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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