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FDA 510(k)

MICRO-BETA U100 SYRINGE

K-Number: K844796 · 1984-12-18

ApplicantOrange Medical Instruments, Inc.
Decision Date1984-12-18
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MICRO-BETA U100 SYRINGE 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 1984-12-18 under 510(k) number K844796. 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 MICRO-BETA U100 SYRINGE?

MICRO-BETA U100 SYRINGE is a medical device that received FDA 510(k) clearance on 1984-12-18. The listed applicant is Orange Medical Instruments, Inc.. The 510(k) number is K844796.

When did MICRO-BETA U100 SYRINGE receive FDA 510(k) clearance?

MICRO-BETA U100 SYRINGE received FDA 510(k) clearance on 1984-12-18, under 510(k) number K844796.

Who is the listed applicant for MICRO-BETA U100 SYRINGE?

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 MICRO-BETA U100 SYRINGE?

The FDA product code for MICRO-BETA U100 SYRINGE is FMF.

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Other records listing Orange Medical Instruments, Inc. as applicant

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K860808CONTINUCATHK851822BETA SCAN TRENDS METERK843882TRENDS LANCETK841369BETA SCAN DRYSTIXK833705BETAJECT BD U100K833706CLICK-COUNT U100 INSULIN SYRINGE

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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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