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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 K002138
FOIA Releasable 510(k) K002138
Device Name PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
Applicant
Maersk Medical A/S
12744 San Fernando Rd.
Sylmar,  CA  91342
Applicant Contact JENNIFER LYONS
Correspondent
Maersk Medical A/S
12744 San Fernando Rd.
Sylmar,  CA  91342
Correspondent Contact JENNIFER LYONS
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FPK  
Date Received07/17/2000
Decision Date 08/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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