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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K851243
Device Name GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION
Applicant
Cook, Inc.
Univ. Of Medicine & Dentistry
Of Nj Rutgers Medical School
New Brunswick,  NJ  08903
Correspondent
Cook, Inc.
Univ. Of Medicine & Dentistry
Of Nj Rutgers Medical School
New Brunswick,  NJ  08903
Regulation Number880.5970
Classification Product Code
LJS  
Date Received02/26/1985
Decision Date 03/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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