The following data is part of a premarket notification filed by Kendall Mcgaw Laboratories, Inc. with the FDA for Add-a-vial Ii Binary Connector.
| Device ID | K900865 |
| 510k Number | K900865 |
| Device Name: | ADD-A-VIAL II BINARY CONNECTOR |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | KENDALL MCGAW LABORATORIES, INC. P.O. BOX 25080 Santa Ana, CA 92799 |
| Contact | Richard J Meader |
| Correspondent | Richard J Meader KENDALL MCGAW LABORATORIES, INC. P.O. BOX 25080 Santa Ana, CA 92799 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-23 |
| Decision Date | 1990-07-11 |