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FDA 510(k)

PANALOK LOOP ANCHOR

K-Number: K040827 · 2004-04-30

ApplicantDepuy Mitek, A Johnson & Johnson Company
Decision Date2004-04-30
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PANALOK LOOP ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. It received FDA 510(k) clearance on 2004-04-30 under 510(k) number K040827. 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 PANALOK LOOP ANCHOR?

PANALOK LOOP ANCHOR is a medical device that received FDA 510(k) clearance on 2004-04-30. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. The 510(k) number is K040827.

When did PANALOK LOOP ANCHOR receive FDA 510(k) clearance?

PANALOK LOOP ANCHOR received FDA 510(k) clearance on 2004-04-30, under 510(k) number K040827.

Who is the listed applicant for PANALOK LOOP ANCHOR?

The FDA 510(k) record lists Depuy Mitek, A Johnson & Johnson Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANALOK LOOP ANCHOR?

The FDA product code for PANALOK LOOP ANCHOR is MAI.

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Related Devices (Code: MAI)

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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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