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 |