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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 K843139
Device Name ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND
Applicant
Chesebrough-Pond'S U.S.A. Co.
Trumbull Industrial Park
Trumbull,  CT  06611
Applicant Contact DE GRAAD
Correspondent
Chesebrough-Pond'S U.S.A. Co.
Trumbull Industrial Park
Trumbull,  CT  06611
Correspondent Contact DE GRAAD
Regulation Number878.4020
Classification Product Code
NAD  
Date Received08/09/1984
Decision Date 11/08/1984
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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