The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace Accu-nate Device.
| Device ID | K891193 |
| 510k Number | K891193 |
| Device Name: | MEDI-TRACE ACCU-NATE DEVICE |
| Classification | Set, Administration, Intravascular |
| Applicant | GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240 |
| Contact | Albert J Amelotte |
| Correspondent | Albert J Amelotte GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-06 |
| Decision Date | 1989-09-19 |