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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Pca
510(k) Number K943310
Device Name MODEL 6100 AMBULATORY INFUSION SYSTEM
Applicant
Pharmacia Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Applicant Contact DAVID H SHORT
Correspondent
Pharmacia Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Correspondent Contact DAVID H SHORT
Regulation Number880.5725
Classification Product Code
MEA  
Date Received07/11/1994
Decision Date 02/21/1995
Decision SE SUBJECT TO TRACKING REG (ST)
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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