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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 K032848
Device Name MEDSAFE SYSTEM INSERTER
Applicant
Medsolve Technologies, LLC
4635 Gershwin Pl.
Woodland Hills,  CA  91364
Applicant Contact SUSAN MCCONNELL
Correspondent
Medsolve Technologies, LLC
4635 Gershwin Pl.
Woodland Hills,  CA  91364
Correspondent Contact SUSAN MCCONNELL
Regulation Number880.6920
Classification Product Code
KZH  
Date Received09/12/2003
Decision Date 04/12/2004
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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