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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bottle, Collection, Vacuum
510(k) Number K851244
Device Name GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
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 Number880.6740
Classification Product Code
KDQ  
Date Received02/26/1985
Decision Date 11/19/1985
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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