The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Codman Certas Plus Programmable Valve; Codman Certas Toll Kit.
| Device ID | K143111 |
| 510k Number | K143111 |
| Device Name: | Codman Certas Plus Programmable Valve; Codman Certas Toll Kit |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | MEDOS INTERNATIONAL SARL CHEMIN-BLANC 38 Le Locle, CH 2400 |
| Contact | Michelle Godin |
| Correspondent | Michelle Godin Codman & Shurtleff, Inc 325 Paramount Drive Raynham, MA 02767 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-29 |
| Decision Date | 2015-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780521358 | K143111 | 000 |
| 10886704079019 | K143111 | 000 |
| 10886704079026 | K143111 | 000 |
| 10381780521136 | K143111 | 000 |
| 10886704079040 | K143111 | 000 |
| 10381780521211 | K143111 | 000 |
| 10381780521259 | K143111 | 000 |
| 10886704079071 | K143111 | 000 |
| 10381780521327 | K143111 | 000 |
| 00381780521337 | K143111 | 000 |
| 10381780521341 | K143111 | 000 |
| 10381780521013 | K143111 | 000 |