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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 K872875
Device Name STRETCH GAUZE BANDAGES
Applicant
Abco Dealers, Inc.
6601 W. Mill Rd.
P.O. Box 23090
Milwaukee,  WI  53218
Applicant Contact MOLLY PRIBEK
Correspondent
Abco Dealers, Inc.
6601 W. Mill Rd.
P.O. Box 23090
Milwaukee,  WI  53218
Correspondent Contact MOLLY PRIBEK
Regulation Number878.4020
Classification Product Code
NAD  
Date Received07/21/1987
Decision Date 09/04/1987
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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