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FDA 510(k)

CMC CABLE FIX

K-Number: K111032 · 2011-08-31

ApplicantInstratek, Inc.
Decision Date2011-08-31
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CMC CABLE FIX is the device name listed in this FDA 510(k) record. The listed applicant is Instratek, Inc.. It received FDA 510(k) clearance on 2011-08-31 under 510(k) number K111032. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMC CABLE FIX?

CMC CABLE FIX is a medical device that received FDA 510(k) clearance on 2011-08-31. The listed applicant is Instratek, Inc.. The 510(k) number is K111032.

When did CMC CABLE FIX receive FDA 510(k) clearance?

CMC CABLE FIX received FDA 510(k) clearance on 2011-08-31, under 510(k) number K111032.

Who is the listed applicant for CMC CABLE FIX?

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

What is the FDA product code for CMC CABLE FIX?

The FDA product code for CMC CABLE FIX is HTN.

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Other records listing Instratek, Inc. as applicant

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Related Devices (Code: HTN)

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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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