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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Occlusive
510(k) Number K872069
Device Name KONTOUR ULTRA SOFT SPONGE #SS144.50
Applicant
Winfield Laboratories, Inc.
1303 Columbia
Suite 207
Richardson,  TX  75081
Applicant Contact ROBERT CUMMINGS
Correspondent
Winfield Laboratories, Inc.
1303 Columbia
Suite 207
Richardson,  TX  75081
Correspondent Contact ROBERT CUMMINGS
Regulation Number878.4020
Classification Product Code
NAD  
Date Received05/29/1987
Decision Date 07/14/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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