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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 K883391
Device Name POLYMER ADHESIVE BANDAGE
Applicant
Marion Laboratories, Inc.
P.O. Box 9627
Kansas City,  MI  64134
Applicant Contact M MONDABAUGH
Correspondent
Marion Laboratories, Inc.
P.O. Box 9627
Kansas City,  MI  64134
Correspondent Contact M MONDABAUGH
Regulation Number878.4020
Classification Product Code
NAD  
Date Received08/09/1988
Decision Date 03/23/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
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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