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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K073664
Device Name FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER
Applicant
Injectimed, Inc.
5616 Mariola Pl NE
Albuquerque,  NM  87111
Applicant Contact RICHARD G HUNTER
Correspondent
Injectimed, Inc.
5616 Mariola Pl NE
Albuquerque,  NM  87111
Correspondent Contact RICHARD G HUNTER
Regulation Number878.4800
Classification Product Code
MDM  
Date Received12/26/2007
Decision Date 08/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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