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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name I.V. Start Kit
510(k) Number K963722
Device Name IV START KIT
Applicant
Grand Medical Products
1300 Remington Rd., Suite K
Schaumburg,  IL  60173
Applicant Contact HARVEY WEISS
Correspondent
Grand Medical Products
1300 Remington Rd., Suite K
Schaumburg,  IL  60173
Correspondent Contact HARVEY WEISS
Regulation Number880.5200
Classification Product Code
LRS  
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
Predetermined Change
Control Plan Authorized		 No
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