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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Wound, Plastic
510(k) Number K832908
Device Name COMFEEL PROTECTIVE RINGS
Applicant
Coloplast A/S
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Coloplast A/S
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4014
Classification Product Code
EYF  
Date Received08/29/1983
Decision Date 12/12/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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