The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Surgical Simplex P With Tobramycin.
| Device ID | K014199 |
| 510k Number | K014199 |
| Device Name: | SURGICAL SIMPLEX P WITH TOBRAMYCIN |
| Classification | Bone Cement |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | William J Cymbaluk |
| Correspondent | William J Cymbaluk HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-21 |
| Decision Date | 2003-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327128421 | K014199 | 000 |