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FDA 510(k)

VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM

K-Number: K123337 · 2013-02-21

ApplicantCaldera Medical
Decision Date2013-02-21
Product CodeOTO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM is the device name listed in this FDA 510(k) record. The listed applicant is Caldera Medical. It received FDA 510(k) clearance on 2013-02-21 under 510(k) number K123337. 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 X 20CM, VERTESSA LITE 11 X 30CM?

VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM is a medical device that received FDA 510(k) clearance on 2013-02-21. The listed applicant is Caldera Medical. The 510(k) number is K123337.

When did VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM receive FDA 510(k) clearance?

VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM received FDA 510(k) clearance on 2013-02-21, under 510(k) number K123337.

Who is the listed applicant for VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM?

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

What is the FDA product code for VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM?

The FDA product code for VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM is OTO.

Related Clinical Trials

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.

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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/SK122794UPSYLON Y MESHBoston Scientific CorpK122968NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015Coloplast Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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