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FDA 510(k)

CUFFLOK ANCHOR

K-Number: K031519 · 2003-06-06

ApplicantMitek Worldwide
Decision Date2003-06-06
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CUFFLOK ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Worldwide. It received FDA 510(k) clearance on 2003-06-06 under 510(k) number K031519. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUFFLOK ANCHOR?

CUFFLOK ANCHOR is a medical device that received FDA 510(k) clearance on 2003-06-06. The listed applicant is Mitek Worldwide. The 510(k) number is K031519.

When did CUFFLOK ANCHOR receive FDA 510(k) clearance?

CUFFLOK ANCHOR received FDA 510(k) clearance on 2003-06-06, under 510(k) number K031519.

Who is the listed applicant for CUFFLOK ANCHOR?

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

What is the FDA product code for CUFFLOK ANCHOR?

The FDA product code for CUFFLOK ANCHOR is MAI.

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Other records listing Mitek Worldwide as applicant

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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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