The following data is part of a premarket notification filed by D.c. Medical Device, Inc. with the FDA for Boger Auto-traction Device.
Device ID | K820663 |
510k Number | K820663 |
Device Name: | BOGER AUTO-TRACTION DEVICE |
Classification | Accessories, Traction |
Applicant | D.C. MEDICAL DEVICE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILZ |
CFR Regulation Number | 890.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-10 |
Decision Date | 1982-05-03 |