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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 K080639
Device Name SYMPHONY GLUCOSE MANAGEMENT SYSTEM
Applicant
ANIMAS CORP.
200 LAWRENCE DR.
WEST CHESTER,  PA  19380
Applicant Contact AMY SMITH
Correspondent
ANIMAS CORP.
200 LAWRENCE DR.
WEST CHESTER,  PA  19380
Correspondent Contact AMY SMITH
Regulation Number880.5725
Classification Product Code
LZG  
Date Received03/06/2008
Decision Date 06/24/2008
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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