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FDA 510(k)

CUFFPATCH

K-Number: K042809 · 2004-11-02

ApplicantOrganogenesis, Inc.
Decision Date2004-11-02
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CUFFPATCH is the device name listed in this FDA 510(k) record. The listed applicant is Organogenesis, Inc.. It received FDA 510(k) clearance on 2004-11-02 under 510(k) number K042809. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUFFPATCH?

CUFFPATCH is a medical device that received FDA 510(k) clearance on 2004-11-02. The listed applicant is Organogenesis, Inc.. The 510(k) number is K042809.

When did CUFFPATCH receive FDA 510(k) clearance?

CUFFPATCH received FDA 510(k) clearance on 2004-11-02, under 510(k) number K042809.

Who is the listed applicant for CUFFPATCH?

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

What is the FDA product code for CUFFPATCH?

The FDA product code for CUFFPATCH is FTM.

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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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