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FDA 510(k)

RESTORELLE POLYPROPYLENE Y MESH

K-Number: K112322 · 2012-05-17

ApplicantColoplast A/S
Decision Date2012-05-17
Product CodeOTO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RESTORELLE POLYPROPYLENE Y MESH is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 2012-05-17 under 510(k) number K112322. The device is classified under product code OTO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESTORELLE POLYPROPYLENE Y MESH?

RESTORELLE POLYPROPYLENE Y MESH is a medical device that received FDA 510(k) clearance on 2012-05-17. The listed applicant is Coloplast A/S. The 510(k) number is K112322.

When did RESTORELLE POLYPROPYLENE Y MESH receive FDA 510(k) clearance?

RESTORELLE POLYPROPYLENE Y MESH received FDA 510(k) clearance on 2012-05-17, under 510(k) number K112322.

Who is the listed applicant for RESTORELLE POLYPROPYLENE Y MESH?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESTORELLE POLYPROPYLENE Y MESH?

The FDA product code for RESTORELLE POLYPROPYLENE Y MESH is OTO.

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Related Devices (Code: OTO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171271Polyform Synthetic MeshBoston Scientific CorporationK132061RESTORELLE M, RESTORELLE XLColoplast Corp.K123028VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESHCaldera Medical, Inc.K123914RESTORELLE Y CONTOURColoplast A/SK123337VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CMCaldera MedicalK122794UPSYLON Y MESHBoston Scientific Corp

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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