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FDA 510(k)

COMFEEL:ALGINATE FILLER

K-Number: K954857 · 1995-11-14

ApplicantColoplast Corp.
Decision Date1995-11-14
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

COMFEEL:ALGINATE FILLER is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 1995-11-14 under 510(k) number K954857. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the COMFEEL:ALGINATE FILLER?

COMFEEL:ALGINATE FILLER is a medical device that received FDA 510(k) clearance on 1995-11-14. The listed applicant is Coloplast Corp.. The 510(k) number is K954857.

When did COMFEEL:ALGINATE FILLER receive FDA 510(k) clearance?

COMFEEL:ALGINATE FILLER received FDA 510(k) clearance on 1995-11-14, under 510(k) number K954857.

Who is the listed applicant for COMFEEL:ALGINATE FILLER?

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:ALGINATE FILLER?

The FDA product code for COMFEEL:ALGINATE FILLER 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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