The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for Specialist(r) Walker.
| Device ID | K924984 |
| 510k Number | K924984 |
| Device Name: | SPECIALIST(R) WALKER |
| Classification | Splint, Extremity, Noninflatable, External, Sterile |
| Applicant | JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham, MA 02767 |
| Contact | Marsha J Stone |
| Correspondent | Marsha J Stone JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham, MA 02767 |
| Product Code | FYH |
| CFR Regulation Number | 878.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-01 |
| Decision Date | 1993-02-01 |