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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K840362
Device Name COMFEEL PASTE
Applicant
Coloplast A/S
200 W. 7th. St.
Suite 1512
Fort Worth ,  TX  76102
Applicant Contact & ASSOCIATE
Correspondent
Coloplast A/S
200 W. 7th. St.
Suite 1512
Fort Worth ,  TX  76102
Correspondent Contact & ASSOCIATE
Date Received01/26/1984
Decision Date 11/07/1984
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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