510(k) Premarket Notification

• Device Classification Name: Set, I.V. Fluid Transfer
• 510(k) Number: K904855
• Device Name: ADD-A-VIAL
• Applicant: KENDALL MCGAW LABORATORIES, INC.; 2525 MCGAW AVE.; P.O. BOX 19791; IRVINE, CA 92713
• Applicant Contact: JOHN G D'ANGELO
• Correspondent: KENDALL MCGAW LABORATORIES, INC.; 2525 MCGAW AVE.; P.O. BOX 19791; IRVINE, CA 92713
• Correspondent Contact: JOHN G D'ANGELO
• Regulation Number: 880.5440
• Classification Product Code: LHI
• Date Received: 10/29/1990
• Decision Date: 11/19/1990
• 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