The following data is part of a premarket notification filed by Protek, Inc. with the FDA for Resubmitted Clw Acetabular Cup W/sulmesh.
| Device ID | K883794 |
| 510k Number | K883794 |
| Device Name: | RESUBMITTED CLW ACETABULAR CUP W/SULMESH |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | PROTEK, INC. 5780 WEST 71ST ST. Indianapolis, IN 46278 |
| Contact | Kenneth Epling |
| Correspondent | Kenneth Epling PROTEK, INC. 5780 WEST 71ST ST. Indianapolis, IN 46278 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-07 |
| Decision Date | 1989-05-26 |