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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 K021439
Device Name MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO
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 Received05/06/2002
Decision Date 05/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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