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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Fluid Delivery
510(k) Number K950861
Device Name RECONSTITUTION ACCESSOREIS
Applicant
Organon, Inc.
375 Mount Pleasant Ave.
West Orange,  NJ  07052
Applicant Contact ALBERT P MAYO
Correspondent
Organon, Inc.
375 Mount Pleasant Ave.
West Orange,  NJ  07052
Correspondent Contact ALBERT P MAYO
Regulation Number880.5440
Classification Product Code
FPK  
Date Received02/27/1995
Decision Date 05/26/1995
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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