The following data is part of a premarket notification filed by Warm & Form, Orthopedic Materials with the FDA for Universal Bucks Traction.
Device ID | K823163 |
510k Number | K823163 |
Device Name: | UNIVERSAL BUCKS TRACTION |
Classification | Component, Traction, Non-invasive |
Applicant | WARM & FORM, ORTHOPEDIC MATERIALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KQZ |
CFR Regulation Number | 888.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-25 |
Decision Date | 1982-11-10 |