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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 K991680
Device Name SOFTINJECT
Applicant
Androsystems Srl
Viale Liegi, 12
Rome,  IT 00198
Applicant Contact ERMANNO GRECO
Correspondent
Androsystems Srl
Viale Liegi, 12
Rome,  IT 00198
Correspondent Contact ERMANNO GRECO
Regulation Number880.6920
Classification Product Code
KZH  
Date Received05/17/1999
Decision Date 06/03/1999
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
Predetermined Change
Control Plan Authorized		 No
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