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FDA 510(k)

SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES

K-Number: K091167 · 2009-08-06

ApplicantShina Corp.
Decision Date2009-08-06
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES is the device name listed in this FDA 510(k) record. The listed applicant is Shina Corp.. It received FDA 510(k) clearance on 2009-08-06 under 510(k) number K091167. 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 SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES?

SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES is a medical device that received FDA 510(k) clearance on 2009-08-06. The listed applicant is Shina Corp.. The 510(k) number is K091167.

When did SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES receive FDA 510(k) clearance?

SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES received FDA 510(k) clearance on 2009-08-06, under 510(k) number K091167.

Who is the listed applicant for SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES?

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

What is the FDA product code for SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES?

The FDA product code for SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES is FMF.

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Other records listing Shina Corp. 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.

K113186STERILE INSULIN PEN NEEDLEK071947VACU-MED BLOOD COLLECTION NEEDLES

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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