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FDA 510(k)

KIM

K-Number: K103022 · 2011-12-20

ApplicantNeomedic International S.L.
Decision Date2011-12-20
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KIM is the device name listed in this FDA 510(k) record. The listed applicant is Neomedic International S.L.. It received FDA 510(k) clearance on 2011-12-20 under 510(k) number K103022. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIM?

KIM is a medical device that received FDA 510(k) clearance on 2011-12-20. The listed applicant is Neomedic International S.L.. The 510(k) number is K103022.

When did KIM receive FDA 510(k) clearance?

KIM received FDA 510(k) clearance on 2011-12-20, under 510(k) number K103022.

Who is the listed applicant for KIM?

The FDA 510(k) record lists Neomedic International S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KIM?

The FDA product code for KIM is OTN.

Other records listing Neomedic International S.L. 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.

K120831ANCHORSURE

Related Devices (Code: OTN)

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.

K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK222293ArcSP Suprapubic Sling SystemUrocure, LLCK222468ArcTO Transobturator Sling SystemUrocure, LLCK211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemCaldera Medical, Inc.K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK210087Athena Surgical RMUS SystemAthena Surgical, LLC

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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