The following data is part of a premarket notification filed by Viratek, Inc. with the FDA for Spag Pak.
| Device ID | K896608 |
| 510k Number | K896608 |
| Device Name: | SPAG PAK |
| Classification | Tent, Oxygen |
| Applicant | VIRATEK, INC. ICN PLAZA 3300 HYLAND AVENUE Costa Mesa, CA 92626 |
| Contact | Alice M Wei |
| Correspondent | Alice M Wei VIRATEK, INC. ICN PLAZA 3300 HYLAND AVENUE Costa Mesa, CA 92626 |
| Product Code | BYL |
| CFR Regulation Number | 868.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-21 |
| Decision Date | 1990-04-09 |