The following data is part of a premarket notification filed by Fournitures Hospitalieres with the FDA for Esop Co-cr Femoral Heads.
| Device ID | K021109 |
| 510k Number | K021109 |
| Device Name: | ESOP CO-CR FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | FOURNITURES HOSPITALIERES C/O PHARMANET, INC. 815 CONNECTICUT AVE NW STE 800 Washington, DC 20006 |
| Contact | Andre Weith |
| Correspondent | Andre Weith FOURNITURES HOSPITALIERES C/O PHARMANET, INC. 815 CONNECTICUT AVE NW STE 800 Washington, DC 20006 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-05 |
| Decision Date | 2002-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661489408731 | K021109 | 000 |
| 03661489408724 | K021109 | 000 |
| 03661489408717 | K021109 | 000 |
| 03661489408700 | K021109 | 000 |
| 03661489408656 | K021109 | 000 |
| 03661489408649 | K021109 | 000 |
| 03661489408632 | K021109 | 000 |
| 03661489408625 | K021109 | 000 |