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FDA 510(k)

MENTOR NOVASILK MESH

K-Number: K053414 · 2005-12-27

ApplicantMentor Corp.
Decision Date2005-12-27
Product CodeOTP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MENTOR NOVASILK MESH is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 2005-12-27 under 510(k) number K053414. The device is classified under product code OTP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR NOVASILK MESH?

MENTOR NOVASILK MESH is a medical device that received FDA 510(k) clearance on 2005-12-27. The listed applicant is Mentor Corp.. The 510(k) number is K053414.

When did MENTOR NOVASILK MESH receive FDA 510(k) clearance?

MENTOR NOVASILK MESH received FDA 510(k) clearance on 2005-12-27, under 510(k) number K053414.

Who is the listed applicant for MENTOR NOVASILK MESH?

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

What is the FDA product code for MENTOR NOVASILK MESH?

The FDA product code for MENTOR NOVASILK MESH is OTP.

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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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