510(k) Premarket Notification

• 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 Number: 880.5440
• Classification Product Code: FPA
• Subsequent Product Code: FPK
• Date Received: 07/17/2000
• 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
• Recalls: CDRH Recalls