The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Modification To Codman Hakim Shunt Systems.
| Device ID | K053350 |
| 510k Number | K053350 |
| Device Name: | MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767 |
| Contact | Brian Kanerviko |
| Correspondent | Brian Kanerviko Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-02 |
| Decision Date | 2006-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780524090 | K053350 | 000 |
| 10886704046981 | K053350 | 000 |
| 10886704046752 | K053350 | 000 |
| 10886704046721 | K053350 | 000 |
| 10886704046080 | K053350 | 000 |
| 10886704046073 | K053350 | 000 |
| 10886704045984 | K053350 | 000 |
| 10886704045755 | K053350 | 000 |
| 10886704045748 | K053350 | 000 |
| 10886704045731 | K053350 | 000 |
| 10886704045724 | K053350 | 000 |
| 10886704045717 | K053350 | 000 |
| 10886704045205 | K053350 | 000 |
| 10886704041900 | K053350 | 000 |
| 10886704041290 | K053350 | 000 |
| 10886704046998 | K053350 | 000 |
| 10886704047001 | K053350 | 000 |
| 10381780519881 | K053350 | 000 |
| 10381780518877 | K053350 | 000 |
| 10381780518860 | K053350 | 000 |
| 10886704073154 | K053350 | 000 |
| 10886704071082 | K053350 | 000 |
| 10886704047421 | K053350 | 000 |
| 10886704047414 | K053350 | 000 |
| 10886704047407 | K053350 | 000 |
| 10886704047391 | K053350 | 000 |
| 10886704047384 | K053350 | 000 |
| 10886704047131 | K053350 | 000 |
| 10886704047032 | K053350 | 000 |
| 10886704047025 | K053350 | 000 |
| 10886704047018 | K053350 | 000 |
| 10886704045076 | K053350 | 000 |