The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for External Drainage System (eds And Eds Ii).
| Device ID | K954021 |
| 510k Number | K954021 |
| Device Name: | EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Anne M Griffin |
| Correspondent | Anne M Griffin 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 | 1995-07-31 |
| Decision Date | 1995-10-24 |