Comfeel Protective Rings

FDA 510(k) K832908 · Coloplast A/S

Substantially Equivalent

510(k) numberK832908

Submission

Device name
Comfeel Protective Rings
Applicant
Coloplast A/S
Mchenry, IL, US
Received
August 29, 1983
Decision date
December 12, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EYF – Protector, Wound, Plastic
Device class
Class I (low risk)
Regulation
21 CFR 878.4014
Specialty
General, Plastic Surgery

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K910104Anti-Fog Disposable IV Induction CoverEYF · Traditional Central Plastic, Inc.04/12/1991SE
K904389Si-ProEYF · Traditional David F. Trungale12/17/1990SE

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Questions and answers

When was Comfeel Protective Rings cleared by the FDA?

Comfeel Protective Rings (K832908) received a 510(k) decision of Substantially Equivalent on December 12, 1983, 105 days after the submission was received.

What is the product code of K832908?

The FDA product code is EYF – Protector, Wound, Plastic, a Class I (low risk) device regulated under 21 CFR 878.4014.