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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, insulin
510(k) Number K032257
Device Name MODEL IR 1200 INSULIN PUMP
Applicant
ANIMAS CORP.
590 E. LANCASTER AVE.
FRAZER,  PA  19355
Applicant Contact MICHAEL J ANDREWS
Correspondent
ANIMAS CORP.
590 E. LANCASTER AVE.
FRAZER,  PA  19355
Correspondent Contact MICHAEL J ANDREWS
Regulation Number880.5725
Classification Product Code
LZG  
Date Received07/22/2003
Decision Date 10/16/2003
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
Recalls CDRH Recalls
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