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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 K760469
Device Name CLEANSING AGENT, NEW WOUND (DEBRISSU)
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 Received08/19/1976
Decision Date 12/16/1976
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
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