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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 K991759
Device Name MAERSK MEDICAL CONTOUR INFUSION SET
Applicant
MAERSK MEDICAL A/S
12744 SAN FERNANDO RD.
SYLMAR,  CA  91342
Applicant Contact DON SELVEY
Correspondent
MAERSK MEDICAL A/S
12744 SAN FERNANDO RD.
SYLMAR,  CA  91342
Correspondent Contact DON SELVEY
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/24/1999
Decision Date 06/25/1999
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
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