The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Codman-medos Valve Shunt System.
| Device ID | K944222 |
| 510k Number | K944222 |
| Device Name: | CODMAN-MEDOS VALVE SHUNT SYSTEM |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 41 PACELLA PARK DR. RANDOLPH IND. PARK Randolph, MA 02368 |
| Contact | Patricia Bankert |
| Correspondent | Patricia Bankert JOHNSON & JOHNSON PROFESSIONALS, INC. 41 PACELLA PARK DR. RANDOLPH IND. PARK Randolph, MA 02368 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-30 |
| Decision Date | 1995-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780515791 | K944222 | 000 |
| 10381780518815 | K944222 | 000 |
| 10886704041665 | K944222 | 000 |
| 10886704041672 | K944222 | 000 |
| 10886704041689 | K944222 | 000 |
| 10886704041696 | K944222 | 000 |
| 10886704041702 | K944222 | 000 |
| 10381780519614 | K944222 | 000 |
| 10381780519621 | K944222 | 000 |
| 10381780519638 | K944222 | 000 |
| 10381780519645 | K944222 | 000 |
| 10381780518822 | K944222 | 000 |
| 10381780518839 | K944222 | 000 |
| 10381780523925 | K944222 | 000 |
| 10381780515487 | K944222 | 000 |
| 10381780515494 | K944222 | 000 |
| 10381780515500 | K944222 | 000 |
| 10886704041726 | K944222 | 000 |