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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 K993184
Device Name R1000 SERIES INSULIN PUMP
Applicant
ANIMAS CORP.
590 e. lancaster ave.
frazer,  PA  19355
Applicant Contact monica ferrante
Correspondent
ANIMAS CORP.
590 e. lancaster ave.
frazer,  PA  19355
Correspondent Contact monica ferrante
Regulation Number880.5725
Classification Product Code
LZG  
Date Received09/23/1999
Decision Date 02/10/2000
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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