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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K945206
Device Name ALLDRESS MULTI LAYERED WOUND DRESSING
Applicant
Scott Health Care
P.O. Box 16598
Fort Worth,  TX  76162
Applicant Contact LARRY BOGART
Correspondent
Scott Health Care
P.O. Box 16598
Fort Worth,  TX  76162
Correspondent Contact LARRY BOGART
Regulation Number880.5090
Classification Product Code
KMF  
Date Received10/25/1994
Decision Date 01/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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