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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 K953584
Device Name LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG
Applicant
ABBOTT LABORATORIES
200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064
Applicant Contact JILL N SACKETT
Correspondent
ABBOTT LABORATORIES
200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064
Correspondent Contact JILL N SACKETT
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/01/1995
Decision Date 10/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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