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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 K050600
Device Name MINILOC SAFETY INFUSION SET
Applicant
SPECIALIZED HEALTH PRODUCTS, INTL.
585 WEST 500 SOUTH
SUITE 200
BOUNTIFUL,  UT  84010
Applicant Contact Mark Nelson
Correspondent
SPECIALIZED HEALTH PRODUCTS, INTL.
585 WEST 500 SOUTH
SUITE 200
BOUNTIFUL,  UT  84010
Correspondent Contact Mark Nelson
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/09/2005
Decision Date 05/12/2005
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
Recalls CDRH Recalls
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