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FDA 510(k)

SHARPSCAN

K-Number: K123807 · 2013-07-23

ApplicantMedical Engineering Development Solutions, Inc.
Decision Date2013-07-23
Product CodeMMK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SHARPSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Medical Engineering Development Solutions, Inc.. It received FDA 510(k) clearance on 2013-07-23 under 510(k) number K123807. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHARPSCAN?

SHARPSCAN is a medical device that received FDA 510(k) clearance on 2013-07-23. The listed applicant is Medical Engineering Development Solutions, Inc.. The 510(k) number is K123807.

When did SHARPSCAN receive FDA 510(k) clearance?

SHARPSCAN received FDA 510(k) clearance on 2013-07-23, under 510(k) number K123807.

Who is the listed applicant for SHARPSCAN?

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

What is the FDA product code for SHARPSCAN?

The FDA product code for SHARPSCAN is MMK.

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Related Devices (Code: MMK)

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.

K260845Huahong Sharps Container (HHR-I, HHR-II)Tianjin Huahong Technology Co., Ltd.K253773Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); GuanhongTaizhou Huangyan Guanhong Plastic Steel Products FactoryK253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd.K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc.K252637Community Containers (Flap and Daisy)Keter Canada, Inc.K231484PureWay 1.4 Quart Sharps CollectorPureway Compliance, 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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