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FDA 510(k)

FLEXIMARC, MODEL CM-0.9-2-10-GG-L

K-Number: K100267 · 2010-02-24

ApplicantCortex Manufacturing, Inc.
Decision Date2010-02-24
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FLEXIMARC, MODEL CM-0.9-2-10-GG-L is the device name listed in this FDA 510(k) record. The listed applicant is Cortex Manufacturing, Inc.. It received FDA 510(k) clearance on 2010-02-24 under 510(k) number K100267. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIMARC, MODEL CM-0.9-2-10-GG-L?

FLEXIMARC, MODEL CM-0.9-2-10-GG-L is a medical device that received FDA 510(k) clearance on 2010-02-24. The listed applicant is Cortex Manufacturing, Inc.. The 510(k) number is K100267.

When did FLEXIMARC, MODEL CM-0.9-2-10-GG-L receive FDA 510(k) clearance?

FLEXIMARC, MODEL CM-0.9-2-10-GG-L received FDA 510(k) clearance on 2010-02-24, under 510(k) number K100267.

Who is the listed applicant for FLEXIMARC, MODEL CM-0.9-2-10-GG-L?

The FDA 510(k) record lists Cortex Manufacturing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXIMARC, MODEL CM-0.9-2-10-GG-L?

The FDA product code for FLEXIMARC, MODEL CM-0.9-2-10-GG-L is IYE.

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Other records listing Cortex Manufacturing, Inc. 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.

K102506MIXED MEDIA MARKER

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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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