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FDA 510(k)

SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE

K-Number: K152803 · 2016-07-12

ApplicantSung Shim Medicare Co., Ltd.
Decision Date2016-07-12
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE is a medical device manufactured by Sung Shim Medicare Co., Ltd.. It received FDA 510(k) clearance on 2016-07-12 under approval number K152803. 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 SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE?

SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE is a medical device that received FDA 510(k) clearance on 2016-07-12. It is manufactured by Sung Shim Medicare Co., Ltd.. The 510(k) number is K152803.

When was SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE approved by the FDA?

SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE received FDA 510(k) clearance on 2016-07-12, under approval number K152803.

What company makes SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE?

SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE is manufactured by Sung Shim Medicare Co., Ltd..

What is the FDA product code for SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE?

The FDA product code for SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE is FMF.

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Sung Shim Medicare Co., Ltd.

K152334Sungshim Insulin Pen Needle

Related Devices (Code: FMF)

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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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