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FDA 510(k)

COMFEEL PASTE

K-Number: K840362 · 1984-11-07

ApplicantColoplast A/S
Decision Date1984-11-07
Product Code
DecisionSubstantially Equivalent

Device Summary

COMFEEL PASTE 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 1984-11-07 under 510(k) number K840362. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFEEL PASTE?

COMFEEL PASTE is a medical device that received FDA 510(k) clearance on 1984-11-07. The listed applicant is Coloplast A/S. The 510(k) number is K840362.

When did COMFEEL PASTE receive FDA 510(k) clearance?

COMFEEL PASTE received FDA 510(k) clearance on 1984-11-07, under 510(k) number K840362.

Who is the listed applicant for COMFEEL PASTE?

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

Related Clinical Trials

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.

Other records listing Coloplast A/S as applicant

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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