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FDA 510(k)

VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH

K-Number: K123028 · 2013-04-25

ApplicantCaldera Medical, Inc.
Decision Date2013-04-25
Product CodeOTO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH is the device name listed in this FDA 510(k) record. The listed applicant is Caldera Medical, Inc.. It received FDA 510(k) clearance on 2013-04-25 under 510(k) number K123028. 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 VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH?

VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH is a medical device that received FDA 510(k) clearance on 2013-04-25. The listed applicant is Caldera Medical, Inc.. The 510(k) number is K123028.

When did VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH receive FDA 510(k) clearance?

VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH received FDA 510(k) clearance on 2013-04-25, under 510(k) number K123028.

Who is the listed applicant for VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH?

The FDA 510(k) record lists Caldera Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH?

The FDA product code for VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE 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.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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