The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Dimension Total Hip Prosthesis.
| Device ID | K853333 |
| 510k Number | K853333 |
| Device Name: | DIMENSION TOTAL HIP PROSTHESIS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Contact | Sam Son |
| Correspondent | Sam Son KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-08 |
| Decision Date | 1985-09-03 |