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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Syringe Needle
510(k) Number K021700
Device Name ANIMUS EZSERTER INFUSION SET INSERTER
Applicant
Animas Corp.
590 E. Lancaster Ave.
Frazer,  PA  19355
Applicant Contact RICHARD MICHELIN
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number880.6920
Classification Product Code
KZH  
Date Received05/23/2002
Decision Date 06/04/2002
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
Predetermined Change
Control Plan Authorized		 No
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