The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Hakim Programmable Valve System.
| Device ID | K974739 |
| 510k Number | K974739 |
| Device Name: | HAKIM PROGRAMMABLE VALVE SYSTEM |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Diane Minear |
| Correspondent | Diane Minear JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. 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 | 1997-12-19 |
| Decision Date | 1998-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704047230 | K974739 | 000 |