510(k) Premarket Notification

• Device Classification Name: Set, I.V. Fluid Transfer
• 510(k) Number: K843639
• Device Name: ADD-A-VIAL SOLUTION TRANSFER DEVICE
• Applicant: American Mcgaw; P.O. Box 1187; Santa Ana, CA 92711
• Applicant Contact: FLOYD BENJAMIN
• Correspondent: American Mcgaw; P.O. Box 1187; Santa Ana, CA 92711
• Correspondent Contact: FLOYD BENJAMIN
• Regulation Number: 880.5440
• Classification Product Code: LHI
• Date Received: 09/17/1984
• Decision Date: 01/14/1985
• 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