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FDA 510(k)

COMFEEL CONTOUR DRESSING

K-Number: K920925 · 1992-05-28

ApplicantColoplast A/S
Decision Date1992-05-28
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMFEEL CONTOUR DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 1992-05-28 under 510(k) number K920925. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFEEL CONTOUR DRESSING?

COMFEEL CONTOUR DRESSING is a medical device that received FDA 510(k) clearance on 1992-05-28. The listed applicant is Coloplast A/S. The 510(k) number is K920925.

When did COMFEEL CONTOUR DRESSING receive FDA 510(k) clearance?

COMFEEL CONTOUR DRESSING received FDA 510(k) clearance on 1992-05-28, under 510(k) number K920925.

Who is the listed applicant for COMFEEL CONTOUR DRESSING?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFEEL CONTOUR DRESSING?

The FDA product code for COMFEEL CONTOUR DRESSING is KMF.

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Related Devices (Code: KMF)

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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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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