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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, Drug
510(k) Number K891189
Device Name WEDGE PRESSURE DRESSING
Applicant
Durden Enterprises, Inc.
P.O. Box 700
Auburn,  GA  30203
Applicant Contact BILL DURDEN
Correspondent
Durden Enterprises, Inc.
P.O. Box 700
Auburn,  GA  30203
Correspondent Contact BILL DURDEN
Classification Product Code
FRO  
Date Received03/06/1989
Decision Date 05/24/1989
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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