The following data is part of a premarket notification filed by Jri Manufacturing Ltd with the FDA for Furlong H-ac Total Hip Replacement System.
| Device ID | K041353 |
| 510k Number | K041353 |
| Device Name: | FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | JRI MANUFACTURING LTD P.O. BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith JRI MANUFACTURING LTD P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-20 |
| Decision Date | 2004-10-08 |