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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 K043587
Device Name SUCRALFATE AND CARAFATE PASTE KITS
Applicant
Patrick D. Mcgrath Ph.D
1471 Greystone Dr.
Gurnee,  IL  60031
Applicant Contact PATRICK D MCGRATH
Correspondent
Patrick D. Mcgrath Ph.D
1471 Greystone Dr.
Gurnee,  IL  60031
Correspondent Contact PATRICK D MCGRATH
Classification Product Code
FRO  
Date Received12/28/2004
Decision Date 02/03/2006
Decision Substantially Equivalent (SESE)
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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