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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 K925001
Device Name CURITY CALCIUM ALGINATE WOUND DRESSING
Applicant
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact PAUL W EVANS
Correspondent
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact PAUL W EVANS
Regulation Number880.5090
Classification Product Code
KMF  
Date Received10/02/1992
Decision Date 01/11/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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