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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K012754
Device Name EZ SET INFUSION SET
Applicant
ANIMAS CORP.
590 E. LANCASTER AVE.
FRAZER,  PA  19355
Applicant Contact MICHAEL J ANDREWS
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/16/2001
Decision Date 08/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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