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FDA 510(k)

DISPOSABLE MICRO-INFUSION SYSTEM

K-Number: K822928 · 1982-10-26

ApplicantOrange Medical Instruments, Inc.
Decision Date1982-10-26
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE MICRO-INFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orange Medical Instruments, Inc.. It received FDA 510(k) clearance on 1982-10-26 under 510(k) number K822928. 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 DISPOSABLE MICRO-INFUSION SYSTEM?

DISPOSABLE MICRO-INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1982-10-26. The listed applicant is Orange Medical Instruments, Inc.. The 510(k) number is K822928.

When did DISPOSABLE MICRO-INFUSION SYSTEM receive FDA 510(k) clearance?

DISPOSABLE MICRO-INFUSION SYSTEM received FDA 510(k) clearance on 1982-10-26, under 510(k) number K822928.

Who is the listed applicant for DISPOSABLE MICRO-INFUSION SYSTEM?

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

What is the FDA product code for DISPOSABLE MICRO-INFUSION SYSTEM?

The FDA product code for DISPOSABLE MICRO-INFUSION SYSTEM is FMF.

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Other records listing Orange Medical Instruments, Inc. as applicant

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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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