510(k) Premarket Notification

• Device Classification Name: Set, I.V. Fluid Transfer
• 510(k) Number: K002705
• Device Name: EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
• Applicant: Baxa Corp.; 13760 E. Arapahoe Rd.; Englewood, CO 80112
• Applicant Contact: CARL STEINECK
• Correspondent: Baxa Corp.; 13760 E. Arapahoe Rd.; Englewood, CO 80112
• Correspondent Contact: CARL STEINECK
• Regulation Number: 880.5440
• Classification Product Code: LHI
• Subsequent Product Code: NEP
• Date Received: 08/30/2000
• Decision Date: 03/28/2001
• 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