The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Luhr Micro System.
| Device ID | K882454 |
| 510k Number | K882454 |
| Device Name: | LUHR MICRO SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Robert E Smith |
| Correspondent | Robert E Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-14 |
| Decision Date | 1988-08-19 |