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FDA 510(k)

DANA 3CC SYRINGE INSULIN RESERVOIR

K-Number: K071418 · 2007-09-04

ApplicantSooil Development Co., Ltd.
Decision Date2007-09-04
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DANA 3CC SYRINGE INSULIN RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Sooil Development Co., Ltd.. It received FDA 510(k) clearance on 2007-09-04 under 510(k) number K071418. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANA 3CC SYRINGE INSULIN RESERVOIR?

DANA 3CC SYRINGE INSULIN RESERVOIR is a medical device that received FDA 510(k) clearance on 2007-09-04. The listed applicant is Sooil Development Co., Ltd.. The 510(k) number is K071418.

When did DANA 3CC SYRINGE INSULIN RESERVOIR receive FDA 510(k) clearance?

DANA 3CC SYRINGE INSULIN RESERVOIR received FDA 510(k) clearance on 2007-09-04, under 510(k) number K071418.

Who is the listed applicant for DANA 3CC SYRINGE INSULIN RESERVOIR?

The FDA 510(k) record lists Sooil Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DANA 3CC SYRINGE INSULIN RESERVOIR?

The FDA product code for DANA 3CC SYRINGE INSULIN RESERVOIR is MRZ.

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 Sooil Development Co., Ltd. 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.

K063126DANA DIABECARE IISK022317DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETSK001604DANA DIABECARE

Related Devices (Code: MRZ)

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.

K230718UTC 3mL Medication CartridgeGilero, LLCK220695Elite Biomedical Solutions Dose Request CordElite Biomedical SolutionsK201634RG 3ml Medication CartridgeChengdu Shifeng Medical Technology Co., Ltd.K193654BlueStar RxWelldoc, Inc.K191910SpaceStation MRIB. Braun Melsugen AGK190013WellDoc BlueStarWelldoc, Inc.

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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