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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K990208
Device Name PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT
Applicant
Science Incorporated
Minnesota Center, Suite 1060
7760 France Ave. S.
Bloomington,  MN  55435
Applicant Contact RALPH E HOGANCAMP
Correspondent
Science Incorporated
Minnesota Center, Suite 1060
7760 France Ave. S.
Bloomington,  MN  55435
Correspondent Contact RALPH E HOGANCAMP
Regulation Number880.5860
Classification Product Code
MEG  
Date Received01/21/1999
Decision Date 03/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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