The following data is part of a premarket notification filed by Cossington Ltd with the FDA for Np Cement Hv;np Cement Lv; Np Cement Hv System; Np Cement Lv System.
| Device ID | K143134 |
| 510k Number | K143134 |
| Device Name: | NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System |
| Classification | Bone Cement |
| Applicant | Cossington Ltd 167-169 London Road Kingston Upon Thames, GB Kt26pt |
| Contact | Diana Mandell Horwitz |
| 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 | No |
| Date Received | 2014-10-31 |
| Decision Date | 2015-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556646410 | K143134 | 000 |
| 00885556646403 | K143134 | 000 |
| 00885556582244 | K143134 | 000 |
| 00885556582213 | K143134 | 000 |