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FDA 510(k)

TOP HYPODERMIC SYRINGE LUER LOCK

K-Number: K843415 · 1984-12-07

ApplicantTop Surgical Manufacturers Co.
Decision Date1984-12-07
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TOP HYPODERMIC SYRINGE LUER LOCK is the device name listed in this FDA 510(k) record. The listed applicant is Top Surgical Manufacturers Co.. It received FDA 510(k) clearance on 1984-12-07 under 510(k) number K843415. 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 TOP HYPODERMIC SYRINGE LUER LOCK?

TOP HYPODERMIC SYRINGE LUER LOCK is a medical device that received FDA 510(k) clearance on 1984-12-07. The listed applicant is Top Surgical Manufacturers Co.. The 510(k) number is K843415.

When did TOP HYPODERMIC SYRINGE LUER LOCK receive FDA 510(k) clearance?

TOP HYPODERMIC SYRINGE LUER LOCK received FDA 510(k) clearance on 1984-12-07, under 510(k) number K843415.

Who is the listed applicant for TOP HYPODERMIC SYRINGE LUER LOCK?

The FDA 510(k) record lists Top Surgical Manufacturers Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOP HYPODERMIC SYRINGE LUER LOCK?

The FDA product code for TOP HYPODERMIC SYRINGE LUER LOCK is FMF.

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Other records listing Top Surgical Manufacturers Co. 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.

K844343TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPEK843313TOP DISPOSABLE SPINAL NEEDLEK843414TOP HYPODERMIC SYRINGE PISTONK841119TOPS DISPOS. INFUSION SET/HEMODIALYSISK841025TOP DISPOSABLE INFUSION SETK832624TOP VENULA I.V. CATHETER SET

View all 12 devices →

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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