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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 K042234
Device Name MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET
Applicant
SPECIALTY HEALTH PRODUCTS, INC.
585 WEST 500 SOUTH
BOUNTIFUL,  UT  84010
Applicant Contact Mark Nelson
Correspondent
SPECIALTY HEALTH PRODUCTS, INC.
585 WEST 500 SOUTH
BOUNTIFUL,  UT  84010
Correspondent Contact Mark Nelson
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/18/2004
Decision Date 09/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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