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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K946326
Device Name DUTEX GAUZE BANDAGE
Applicant
Dumex Medical Surgical Products, Ltd.
104 Shorting Rd.
Toronto, Orntario,  CA M1S 3S4
Applicant Contact ANGELO GUERRIERO
Correspondent
Dumex Medical Surgical Products, Ltd.
104 Shorting Rd.
Toronto, Orntario,  CA M1S 3S4
Correspondent Contact ANGELO GUERRIERO
Classification Product Code
EFQ  
Date Received12/22/1994
Decision Date 01/24/1995
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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