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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 K073050
Device Name SAFESTEP MAX POWER-INJECTABLE INFUSION SET
Applicant
SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC.
585 WEST 500 SOUTH
BOUNTIFUL,  UT  84010
Applicant Contact Mark Nelson
Correspondent
SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC.
585 WEST 500 SOUTH
BOUNTIFUL,  UT  84010
Correspondent Contact Mark Nelson
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/29/2007
Decision Date 01/25/2008
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
Recalls CDRH Recalls
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