The following data is part of a premarket notification filed by Geneva Laboratories, Inc. with the FDA for Gent-l-kare Sterile I.v. Start Kit.
| Device ID | K844255 |
| 510k Number | K844255 |
| Device Name: | GENT-L-KARE STERILE I.V. START KIT |
| Classification | Set, Administration, Intravascular |
| Applicant | GENEVA LABORATORIES, INC. P.O. BOX 444 Elkhorn, WI 53121 |
| Contact | Gary L Swanson |
| Correspondent | Gary L Swanson GENEVA LABORATORIES, INC. P.O. BOX 444 Elkhorn, WI 53121 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-02 |
| Decision Date | 1984-12-19 |