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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 K973509
Device Name KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
Applicant
Kendall Healthcare Products Co. Div.Of Tyco Health
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact JAN L EFFLANDT
Correspondent
Kendall Healthcare Products Co. Div.Of Tyco Health
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact JAN L EFFLANDT
Regulation Number880.5090
Classification Product Code
KMF  
Date Received09/16/1997
Decision Date 12/04/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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