The following data is part of a premarket notification filed by Ipax, Inc. with the FDA for Kpe 220 Ts, Nonsterile.
| Device ID | K914221 |
| 510k Number | K914221 |
| Device Name: | KPE 220 TS, NONSTERILE |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| 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 | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-23 |
| Decision Date | 1991-10-25 |