COMFEEL PROTECTIVE RINGS— 510(k) K832908

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K832908 for COMFEEL PROTECTIVE RINGS, Substantially Equivalent on 1983-12-12. Applicant: Coloplast A/S. Device class: 1.

Clearance details

Applicant: Coloplast A/S
Product code: Code EYF
Device class: Class 1
Regulation: 21 CFR 878.4014
Advisory panel: General, Plastic Surgery
Date received: 1983-08-29
Decision date: 1983-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EYF

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K911407 — HARDING STERNAL SHIELD1991-07-05
K910104 — ANTI-FOG DISPOSABLE IV INDUCTION COVER1991-04-12
K904389 — SI-PRO1990-12-17

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Data sourced from openFDA. This site is unofficial and independent of the FDA.