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FDA 510(k)

COMFEEL POWDER

K-Number: K834343 · 1984-11-08

ApplicantColoplast A/S
Decision Date1984-11-08
Product CodeKOZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COMFEEL POWDER 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 1984-11-08 under 510(k) number K834343. The device is classified under product code KOZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFEEL POWDER?

COMFEEL POWDER is a medical device that received FDA 510(k) clearance on 1984-11-08. The listed applicant is Coloplast A/S. The 510(k) number is K834343.

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

COMFEEL POWDER received FDA 510(k) clearance on 1984-11-08, under 510(k) number K834343.

Who is the listed applicant for COMFEEL POWDER?

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 POWDER?

The FDA product code for COMFEEL POWDER is KOZ.

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Related Devices (Code: KOZ)

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.

K905206INCARE PINSITE DRESSINGHollister, Inc.K905688CUTINOVA HYDROBeiersdorf, Inc.K905069IODOSORB GELPerstorp AB C/O Robert Joel SlomoffK904604REDI-RELEASE ABSORBENT DRESSINGFountain Pharmaceuticals, Inc.K896828BIOCLUSIVE(R) ABSORBENT DRESSINGJohnson & Johnson InternationalK903645DERMASORB WOUND CONTACT LAYER DRESSINGConvatec, A Division of E.R. Squibb & Sons

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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