The following data is part of a premarket notification filed by Fournitures Hospitalieres with the FDA for Esop S/c Femoral Stem.
| Device ID | K964878 |
| 510k Number | K964878 |
| Device Name: | ESOP S/C FEMORAL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | FOURNITURES HOSPITALIERES 1700 ROCKVILLE PIKE SUITE 450 Rockville, MD 20852 |
| Contact | Ben Van Der Kooij |
| Correspondent | Ben Van Der Kooij FOURNITURES HOSPITALIERES 1700 ROCKVILLE PIKE SUITE 450 Rockville, MD 20852 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-05 |
| Decision Date | 1998-03-05 |
| Summary: | summary |