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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 K980779
Device Name THALAFIX NATURAL SEA SALT DRESSING
Applicant
Dumex Medical Surgical Products, Ltd.
104 Shorting Rd.
Toronto, Orntario,  CA M1S 3S4
Applicant Contact SHARMINI ATHERAY, M.SC
Correspondent
Dumex Medical Surgical Products, Ltd.
104 Shorting Rd.
Toronto, Orntario,  CA M1S 3S4
Correspondent Contact SHARMINI ATHERAY, M.SC
Regulation Number880.5090
Classification Product Code
KMF  
Date Received03/02/1998
Decision Date 06/26/1998
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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