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FDA 510(k)

CALDERA MESH

K-Number: K060004 · 2006-02-22

ApplicantCaldera Medical, Inc.
Decision Date2006-02-22
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CALDERA 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 2006-02-22 under 510(k) number K060004. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALDERA MESH?

CALDERA MESH is a medical device that received FDA 510(k) clearance on 2006-02-22. The listed applicant is Caldera Medical, Inc.. The 510(k) number is K060004.

When did CALDERA MESH receive FDA 510(k) clearance?

CALDERA MESH received FDA 510(k) clearance on 2006-02-22, under 510(k) number K060004.

Who is the listed applicant for CALDERA 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 CALDERA MESH?

The FDA product code for CALDERA MESH is FTL.

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Related Devices (Code: FTL)

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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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