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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 K942459
Device Name CURASALT HYPERTONIC SALINE DRESSING
Applicant
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact DAVID A OLSON
Correspondent
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact DAVID A OLSON
Regulation Number880.5090
Classification Product Code
KMF  
Date Received05/24/1994
Decision Date 06/27/1994
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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