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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Beads, Hydrophilic, For Wound Exudate Absorption
510(k) Number K800737
Device Name DEBRISAN (DEXTRANOMER) PASTE
Applicant
Pharmaseal Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Pharmaseal Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4018
Classification Product Code
KOZ  
Date Received04/02/1980
Decision Date 08/04/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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