The following data is part of a premarket notification filed by Warm & Form, Orthopedic Materials with the FDA for Wrist Spling & Forearm Splint.
Device ID | K823165 |
510k Number | K823165 |
Device Name: | WRIST SPLING & FOREARM SPLINT |
Classification | Splint, Hand, And Components |
Applicant | WARM & FORM, ORTHOPEDIC MATERIALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILH |
CFR Regulation Number | 890.3475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-25 |
Decision Date | 1982-11-16 |