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FDA 510(k)

RETRACTABLE NEEDLE 3CC SYRINGE

K-Number: K881454 · 1988-12-08

ApplicantKenmar Medical
Decision Date1988-12-08
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RETRACTABLE NEEDLE 3CC SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Kenmar Medical. It received FDA 510(k) clearance on 1988-12-08 under 510(k) number K881454. 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 RETRACTABLE NEEDLE 3CC SYRINGE?

RETRACTABLE NEEDLE 3CC SYRINGE is a medical device that received FDA 510(k) clearance on 1988-12-08. The listed applicant is Kenmar Medical. The 510(k) number is K881454.

When did RETRACTABLE NEEDLE 3CC SYRINGE receive FDA 510(k) clearance?

RETRACTABLE NEEDLE 3CC SYRINGE received FDA 510(k) clearance on 1988-12-08, under 510(k) number K881454.

Who is the listed applicant for RETRACTABLE NEEDLE 3CC SYRINGE?

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

What is the FDA product code for RETRACTABLE NEEDLE 3CC SYRINGE?

The FDA product code for RETRACTABLE NEEDLE 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

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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