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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wound dressing kit
510(k) Number K963719
Device Name CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
Applicant
GRAND MEDICAL PRODUCTS
1300 REMINGTON ROAD, SUITE K
SCHAUMBURG,  IL  60173
Applicant Contact HARVEY WEISS
Correspondent
GRAND MEDICAL PRODUCTS
1300 REMINGTON ROAD, SUITE K
SCHAUMBURG,  IL  60173
Correspondent Contact HARVEY WEISS
Regulation Number880.5075
Classification Product Code
MCY  
Date Received09/16/1996
Decision Date 11/27/1996
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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