The following data is part of a premarket notification filed by Geneva Laboratories, Inc. with the FDA for University Of Chicago Vascular Angiogram.
| Device ID | K843090 |
| 510k Number | K843090 |
| Device Name: | UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM |
| 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 | 1984-08-06 |
| Decision Date | 1984-12-04 |