The following data is part of a premarket notification filed by Ipax, Inc. with the FDA for Procedual Changes/assembly Process For Plus Paks.
| Device ID | K873097 |
| 510k Number | K873097 |
| Device Name: | PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS |
| Classification | Catheter, Continuous Irrigation |
| Applicant | IPAX, INC. 2109 WEST AMHERST AVE. Englewood, CO 80110 |
| Contact | Pennell |
| Correspondent | Pennell IPAX, INC. 2109 WEST AMHERST AVE. Englewood, CO 80110 |
| Product Code | GBQ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-27 |
| Decision Date | 1987-09-04 |