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FDA 510(k)

COMFEEL PASTE

K-Number: K833565 · 1984-01-30

ApplicantColoplast A/S
Decision Date1984-01-30
Product CodeEXB
Advisory CommitteeGU
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 1984-01-30 under 510(k) number K833565. The device is classified under product code EXB. It was reviewed by the GU advisory panel. 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 1984-01-30. The listed applicant is Coloplast A/S. The 510(k) number is K833565.

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

COMFEEL PASTE received FDA 510(k) clearance on 1984-01-30, under 510(k) number K833565.

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.

What is the FDA product code for COMFEEL PASTE?

The FDA product code for COMFEEL PASTE is EXB.

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Other records listing Coloplast A/S as applicant

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Related Devices (Code: EXB)

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.

K252140Heylo™ SystemColoplast Corp.K181643SmartBag (SmartPouch)11 Health Technologies LimitedK922730LAKE OSTOMY CARE SETLake Medical Products, Inc.K882878ODOR-END EMERGENCY CLEAN UP POWDERCdc Products Corp.K881636CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)Coloplast A/SK880306EMERGENCY-CLEAN UP(TM) ECPCdc Products Corp.

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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