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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 K042873
Device Name ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
Applicant
ANIMAS CORP.
200 LAWRENCE DR.
WEST CHESTER,  PA  19380
Applicant Contact THOMAS L PARKER
Correspondent
ANIMAS CORP.
200 LAWRENCE DR.
WEST CHESTER,  PA  19380
Correspondent Contact THOMAS L PARKER
Regulation Number880.5725
Classification Product Code
LZG  
Date Received10/18/2004
Decision Date 12/10/2004
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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