The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Codman Lumbar Drainage Catheter Kit.
| Device ID | K964923 |
| 510k Number | K964923 |
| Device Name: | CODMAN LUMBAR DRAINAGE CATHETER KIT |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Deana M Boushell |
| Correspondent | Deana M Boushell JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-09 |
| Decision Date | 1997-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704040811 | K964923 | 000 |
| 00382830050531 | K964923 | 000 |