The following data is part of a premarket notification filed by Cossington Ltd with the FDA for Np Cement Hv Genta;np Cement Lv Genta;np Cement Hv System Genta;np Cement Lv System Genta.
| Device ID | K143100 |
| 510k Number | K143100 |
| Device Name: | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta |
| Classification | Bone Cement |
| Applicant | Cossington Ltd 167-169 London Road Kingston Upon Thames, GB Kt26pt |
| Contact | Diana Mandell Horwitz, Ph.d.,rac |
| Correspondent | Diane Mandell Horwitz,ph.d., Rac Mandell Horwitz Consultants LLC 2995 Steven Martin Dr. Fairfax, VA 22031 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-10-28 |
| Decision Date | 2015-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556582268 | K143100 | 000 |
| 00885556582251 | K143100 | 000 |
| 00885556582237 | K143100 | 000 |
| 00885556582220 | K143100 | 000 |