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FDA 510(k)

SYRINGES(3-PARTS SINGLE USE)

K-Number: K822533 · 1982-09-17

ApplicantImpex Laboratories
Decision Date1982-09-17
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYRINGES(3-PARTS SINGLE USE) is the device name listed in this FDA 510(k) record. The listed applicant is Impex Laboratories. It received FDA 510(k) clearance on 1982-09-17 under 510(k) number K822533. 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 SYRINGES(3-PARTS SINGLE USE)?

SYRINGES(3-PARTS SINGLE USE) is a medical device that received FDA 510(k) clearance on 1982-09-17. The listed applicant is Impex Laboratories. The 510(k) number is K822533.

When did SYRINGES(3-PARTS SINGLE USE) receive FDA 510(k) clearance?

SYRINGES(3-PARTS SINGLE USE) received FDA 510(k) clearance on 1982-09-17, under 510(k) number K822533.

Who is the listed applicant for SYRINGES(3-PARTS SINGLE USE)?

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

What is the FDA product code for SYRINGES(3-PARTS SINGLE USE)?

The FDA product code for SYRINGES(3-PARTS SINGLE USE) 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 Impex Laboratories 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.

K822534NEEDLES(HYPODERMIC)K822532SYRINGES(2-PARTS SINGLE USE)

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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