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 |