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FDA 510(k)

COMFEEL SEASORB DRESSING

K-Number: K983519 · 1998-12-30

ApplicantColoplast Corp.
Decision Date1998-12-30
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMFEEL SEASORB DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 1998-12-30 under 510(k) number K983519. 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 SEASORB DRESSING?

COMFEEL SEASORB DRESSING is a medical device that received FDA 510(k) clearance on 1998-12-30. The listed applicant is Coloplast Corp.. The 510(k) number is K983519.

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

COMFEEL SEASORB DRESSING received FDA 510(k) clearance on 1998-12-30, under 510(k) number K983519.

Who is the listed applicant for COMFEEL SEASORB DRESSING?

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

What is the FDA product code for COMFEEL SEASORB DRESSING?

The FDA product code for COMFEEL SEASORB DRESSING is KMF.

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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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