The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Codman Intracranial Bolt.
| Device ID | K974088 |
| 510k Number | K974088 |
| Device Name: | CODMAN INTRACRANIAL BOLT |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | James M Flaherty Jr. |
| Correspondent | James M Flaherty Jr. JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-30 |
| Decision Date | 1998-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704048626 | K974088 | 000 |