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FDA 510(k)

COMFEEL TRANSPARENT DRESSING

K-Number: K894916 · 1989-09-26

ApplicantColoplast A/S
Decision Date1989-09-26
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMFEEL TRANSPARENT 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 1989-09-26 under 510(k) number K894916. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFEEL TRANSPARENT DRESSING?

COMFEEL TRANSPARENT DRESSING is a medical device that received FDA 510(k) clearance on 1989-09-26. The listed applicant is Coloplast A/S. The 510(k) number is K894916.

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

COMFEEL TRANSPARENT DRESSING received FDA 510(k) clearance on 1989-09-26, under 510(k) number K894916.

Who is the listed applicant for COMFEEL TRANSPARENT 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 TRANSPARENT DRESSING?

The FDA product code for COMFEEL TRANSPARENT DRESSING is KGX.

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Related Devices (Code: KGX)

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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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