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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 K040779
Device Name RESTORE WOUND CLEANSER
Applicant
HOLLISTER, INC.
2000 HOLLISTER DR.
LIBERTYVILLE,  IL  60048
Applicant Contact JOSEPH S TOKARZ
Correspondent
HOLLISTER, INC.
2000 HOLLISTER DR.
LIBERTYVILLE,  IL  60048
Correspondent Contact JOSEPH S TOKARZ
Regulation Number880.5090
Classification Product Code
KMF  
Date Received03/26/2004
Decision Date 05/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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