The following data is part of a premarket notification filed by Zee Medical Products Co., Inc. with the FDA for Zee Extrication Device.
Device ID | K812342 |
510k Number | K812342 |
Device Name: | ZEE EXTRICATION DEVICE |
Classification | Orthosis, Cervical-thoracic, Rigid |
Applicant | ZEE MEDICAL PRODUCTS CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IQF |
CFR Regulation Number | 890.3490 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-08-18 |
Decision Date | 1981-09-21 |