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FDA 510(k)

RESTORELLE M, RESTORELLE XL

K-Number: K132061 · 2013-08-02

ApplicantColoplast Corp.
Decision Date2013-08-02
Product CodeOTO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RESTORELLE M, RESTORELLE XL is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2013-08-02 under 510(k) number K132061. 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 M, RESTORELLE XL?

RESTORELLE M, RESTORELLE XL is a medical device that received FDA 510(k) clearance on 2013-08-02. The listed applicant is Coloplast Corp.. The 510(k) number is K132061.

When did RESTORELLE M, RESTORELLE XL receive FDA 510(k) clearance?

RESTORELLE M, RESTORELLE XL received FDA 510(k) clearance on 2013-08-02, under 510(k) number K132061.

Who is the listed applicant for RESTORELLE M, RESTORELLE XL?

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

What is the FDA product code for RESTORELLE M, RESTORELLE XL?

The FDA product code for RESTORELLE M, RESTORELLE XL 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 CorporationK123028VERTESSA 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 CorpK122968NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015Coloplast 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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