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FDA 510(k)

UGYTEX SUAL KNIT MESH

K-Number: K051503 · 2005-08-05

ApplicantSofradim Production
Decision Date2005-08-05
Product CodeOTP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

UGYTEX SUAL KNIT MESH is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2005-08-05 under 510(k) number K051503. 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 UGYTEX SUAL KNIT MESH?

UGYTEX SUAL KNIT MESH is a medical device that received FDA 510(k) clearance on 2005-08-05. The listed applicant is Sofradim Production. The 510(k) number is K051503.

When did UGYTEX SUAL KNIT MESH receive FDA 510(k) clearance?

UGYTEX SUAL KNIT MESH received FDA 510(k) clearance on 2005-08-05, under 510(k) number K051503.

Who is the listed applicant for UGYTEX SUAL KNIT MESH?

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

What is the FDA product code for UGYTEX SUAL KNIT MESH?

The FDA product code for UGYTEX SUAL KNIT MESH is OTP.

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Related Devices (Code: 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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