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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 K051943
Device Name SUREFLOW SAFETY INFUSION DEVICE
Applicant
Intrasafe Medical, LLC
28202 Cabot Rd., Suite 300
Laguna Niguel,  CA  92677
Applicant Contact SHEPARD G BENTLEY
Correspondent
Intrasafe Medical, LLC
28202 Cabot Rd., Suite 300
Laguna Niguel,  CA  92677
Correspondent Contact SHEPARD G BENTLEY
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/18/2005
Decision Date 10/04/2005
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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