The following data is part of a premarket notification filed by Ipax, Inc. with the FDA for Kpe Plus-pak Surgical System.
| Device ID | K833962 |
| 510k Number | K833962 |
| Device Name: | KPE PLUS-PAK SURGICAL SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | IPAX, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-16 |
| Decision Date | 1984-03-12 |