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FDA 510(k)

STERILE DISPOSABLE SYRINGE(3 PIECES)

K-Number: K852819 · 1985-09-20

ApplicantFabersanitas, S.A.
Decision Date1985-09-20
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE DISPOSABLE SYRINGE(3 PIECES) is the device name listed in this FDA 510(k) record. The listed applicant is Fabersanitas, S.A.. It received FDA 510(k) clearance on 1985-09-20 under 510(k) number K852819. 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 STERILE DISPOSABLE SYRINGE(3 PIECES)?

STERILE DISPOSABLE SYRINGE(3 PIECES) is a medical device that received FDA 510(k) clearance on 1985-09-20. The listed applicant is Fabersanitas, S.A.. The 510(k) number is K852819.

When did STERILE DISPOSABLE SYRINGE(3 PIECES) receive FDA 510(k) clearance?

STERILE DISPOSABLE SYRINGE(3 PIECES) received FDA 510(k) clearance on 1985-09-20, under 510(k) number K852819.

Who is the listed applicant for STERILE DISPOSABLE SYRINGE(3 PIECES)?

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

What is the FDA product code for STERILE DISPOSABLE SYRINGE(3 PIECES)?

The FDA product code for STERILE DISPOSABLE SYRINGE(3 PIECES) is FMF.

Related Clinical Trials

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.

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Other records listing Fabersanitas, S.A. 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.

K852818STERILE DISPOSABLE SYRINGES(2 PIECES)K852817STERILE, DISPOSABLE NEEDLE

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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