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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 K140175
Device Name INTRAVASCULAR ADMINISTRATION SET
Applicant
Delta Med Spa
Piazza Albania, N'10
Rome,  IT 00153
Applicant Contact ROGER GRAY
Correspondent
Delta Med Spa
Piazza Albania, N'10
Rome,  IT 00153
Correspondent Contact ROGER GRAY
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/23/2014
Decision Date 08/05/2014
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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