COMFEEL PROTECTIVE RINGS

Protector, Wound, Plastic

COLOPLAST A/S

The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Comfeel Protective Rings.

Pre-market Notification Details

Device IDK832908
510k NumberK832908
Device Name:COMFEEL PROTECTIVE RINGS
ClassificationProtector, Wound, Plastic
Applicant COLOPLAST A/S 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEYF  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-29
Decision Date1983-12-12

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