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FDA 510(k)

PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES

K-Number: K072951 · 2007-12-19

ApplicantSofradim Production
Decision Date2007-12-19
Product CodeOTP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2007-12-19 under 510(k) number K072951. 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 PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES?

PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES is a medical device that received FDA 510(k) clearance on 2007-12-19. The listed applicant is Sofradim Production. The 510(k) number is K072951.

When did PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES receive FDA 510(k) clearance?

PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES received FDA 510(k) clearance on 2007-12-19, under 510(k) number K072951.

Who is the listed applicant for PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES?

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 PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES?

The FDA product code for PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES 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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