The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Deseret Introducer Set.
| Device ID | K844840 |
| 510k Number | K844840 |
| Device Name: | DESERET INTRODUCER SET |
| Classification | Introducer, Catheter |
| Applicant | PARKE-DAVIS CO. 870 PARKDALE RD. Rochester, MI 48307 |
| Contact | Cleary |
| Correspondent | Cleary PARKE-DAVIS CO. 870 PARKDALE RD. Rochester, MI 48307 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-12 |
| Decision Date | 1985-05-16 |