The following data is part of a premarket notification filed by Lima Intl. Corp. with the FDA for Cl Universal Hip Device.
| Device ID | K885146 |
| 510k Number | K885146 |
| Device Name: | CL UNIVERSAL HIP DEVICE |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | LIMA INTL. CORP. 392 WAMPANOAG TRAIL E Providence, RI 02915 |
| Contact | Pollonio-lister |
| Correspondent | Pollonio-lister LIMA INTL. CORP. 392 WAMPANOAG TRAIL E Providence, RI 02915 |
| Product Code | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-15 |
| Decision Date | 1989-04-24 |