ADD-A-VIAL

Set, I.v. Fluid Transfer

KENDALL MCGAW LABORATORIES, INC.

The following data is part of a premarket notification filed by Kendall Mcgaw Laboratories, Inc. with the FDA for Add-a-vial.

Pre-market Notification Details

• Device ID: K904855
• 510k Number: K904855
• Device Name: ADD-A-VIAL
• Classification: Set, I.v. Fluid Transfer
• Applicant: KENDALL MCGAW LABORATORIES, INC. 2525 MCGAW AVE. P.O. BOX 19791 Irvine, CA 92713
• Contact: John G D'angelo
• Correspondent: John G D'angelo; KENDALL MCGAW LABORATORIES, INC. 2525 MCGAW AVE. P.O. BOX 19791 Irvine, CA 92713
• Product Code: LHI
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-10-29
• Decision Date: 1990-11-19