The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Kirschner Bipolar Endoprosthetic Head.
| Device ID | K853795 |
| 510k Number | K853795 |
| Device Name: | KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| 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 | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-11 |
| Decision Date | 1985-11-22 |