The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Coman(r) Cu-11 Model Number 82-6634.
| Device ID | K945585 |
| 510k Number | K945585 |
| Device Name: | COMAN(R) CU-11 MODEL NUMBER 82-6634 |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N. Raritan, NJ 08869 |
| Contact | Patricia Bankert |
| Correspondent | Patricia Bankert JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N. Raritan, NJ 08869 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704042341 | K945585 | 000 |
| 10886704043416 | K945585 | 000 |
| 10886704043386 | K945585 | 000 |
| 10886704043355 | K945585 | 000 |
| 10886704043348 | K945585 | 000 |
| 10886704043331 | K945585 | 000 |
| 10886704043263 | K945585 | 000 |
| 10886704043232 | K945585 | 000 |
| 10886704042464 | K945585 | 000 |
| 10886704042457 | K945585 | 000 |
| 10886704042440 | K945585 | 000 |
| 10886704042433 | K945585 | 000 |
| 10886704042426 | K945585 | 000 |
| 10886704042365 | K945585 | 000 |
| 10886704043430 | K945585 | 000 |
| 10886704043454 | K945585 | 000 |
| 10381780521907 | K945585 | 000 |
| 10381780521846 | K945585 | 000 |
| 10381780521839 | K945585 | 000 |
| 10381780521808 | K945585 | 000 |
| 10381780520559 | K945585 | 000 |
| 10381780520542 | K945585 | 000 |
| 10381780520535 | K945585 | 000 |
| 10381780520528 | K945585 | 000 |
| 10381780520511 | K945585 | 000 |
| 10381780520481 | K945585 | 000 |
| 10381780520443 | K945585 | 000 |
| 10886704043515 | K945585 | 000 |
| 10886704043492 | K945585 | 000 |
| 10886704043447 | K945585 | 000 |