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FDA 510(k)

COMFEEL PROTECTIVE RINGS

K-Number: K832908 · 1983-12-12

ApplicantColoplast A/S
Decision Date1983-12-12
Product CodeEYF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COMFEEL PROTECTIVE RINGS 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 1983-12-12 under 510(k) number K832908. The device is classified under product code EYF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFEEL PROTECTIVE RINGS?

COMFEEL PROTECTIVE RINGS is a medical device that received FDA 510(k) clearance on 1983-12-12. The listed applicant is Coloplast A/S. The 510(k) number is K832908.

When did COMFEEL PROTECTIVE RINGS receive FDA 510(k) clearance?

COMFEEL PROTECTIVE RINGS received FDA 510(k) clearance on 1983-12-12, under 510(k) number K832908.

Who is the listed applicant for COMFEEL PROTECTIVE RINGS?

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 PROTECTIVE RINGS?

The FDA product code for COMFEEL PROTECTIVE RINGS is EYF.

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Related Devices (Code: EYF)

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.

K922785IRRIVAGEAutovageK911407HARDING STERNAL SHIELDHarding Medical DevicesK910104ANTI-FOG DISPOSABLE IV INDUCTION COVERCentral Plastic, Inc.K904389SI-PRODavid F. Trungale

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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