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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze / Sponge,Nonresorbable For External Use
510(k) Number K910857
Device Name ALLDRESS MULTI LAYERED WOUND DRESSING
Applicant
Scott Health Care
Scott Plaza Iii
Philadelphia,  PA  19113 -1585
Applicant Contact RICHARD A HAMER
Correspondent
Scott Health Care
Scott Plaza Iii
Philadelphia,  PA  19113 -1585
Correspondent Contact RICHARD A HAMER
Regulation Number878.4014
Classification Product Code
NAB  
Date Received02/28/1991
Decision Date 04/12/1991
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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