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FDA 510(k)

COMFEEL(R) WOUND DRESSING SD

K-Number: K925376 · 1993-03-16

ApplicantColoplast A/S
Decision Date1993-03-16
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMFEEL(R) WOUND DRESSING SD 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 1993-03-16 under 510(k) number K925376. 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(R) WOUND DRESSING SD?

COMFEEL(R) WOUND DRESSING SD is a medical device that received FDA 510(k) clearance on 1993-03-16. The listed applicant is Coloplast A/S. The 510(k) number is K925376.

When did COMFEEL(R) WOUND DRESSING SD receive FDA 510(k) clearance?

COMFEEL(R) WOUND DRESSING SD received FDA 510(k) clearance on 1993-03-16, under 510(k) number K925376.

Who is the listed applicant for COMFEEL(R) WOUND DRESSING SD?

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(R) WOUND DRESSING SD?

The FDA product code for COMFEEL(R) WOUND DRESSING SD 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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