The following data is part of a premarket notification filed by Zee Medical Products Co., Inc. with the FDA for Zee Traction Splint.
Device ID | K813016 |
510k Number | K813016 |
Device Name: | ZEE TRACTION SPLINT |
Classification | Apparatus, Traction, Non-powered |
Applicant | ZEE MEDICAL PRODUCTS CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HST |
CFR Regulation Number | 888.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-27 |
Decision Date | 1981-11-24 |