The following data is part of a premarket notification filed by Deseret Medical, Inc. with the FDA for Vialon Obturator.
| Device ID | K904121 |
| 510k Number | K904121 |
| Device Name: | VIALON OBTURATOR |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | DESERET MEDICAL, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Contact | Charles J Welle |
| Correspondent | Charles J Welle DESERET MEDICAL, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-06 |
| Decision Date | 1990-11-08 |