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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, X-Ray Detectable
510(k) Number K941217
Device Name DUPAQUE SPONGE
Applicant
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
104 SHORTING ROAD
TORONTO, ONTARIO,  CA M1S 3S4
Applicant Contact BILL GOODWIN
Correspondent
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
104 SHORTING ROAD
TORONTO, ONTARIO,  CA M1S 3S4
Correspondent Contact BILL GOODWIN
Regulation Number878.4450
Classification Product Code
GDY  
Date Received03/14/1994
Decision Date 04/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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