FDA 510(k)

CAPTION APPLICATOR

K-Number: K063535 · 2007-02-26

Decision Date2007-02-26

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CAPTION APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2007-02-26 under 510(k) number K063535. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPTION APPLICATOR?

CAPTION APPLICATOR is a medical device that received FDA 510(k) clearance on 2007-02-26. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K063535.

When did CAPTION APPLICATOR receive FDA 510(k) clearance?

CAPTION APPLICATOR received FDA 510(k) clearance on 2007-02-26, under 510(k) number K063535.

Who is the listed applicant for CAPTION APPLICATOR?

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

What is the FDA product code for CAPTION APPLICATOR?

The FDA product code for CAPTION APPLICATOR is FMF.

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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.