The following data is part of a premarket notification filed by Akron Medical Corp. with the FDA for Tec Traction Machine.
Device ID | K834405 |
510k Number | K834405 |
Device Name: | TEC TRACTION MACHINE |
Classification | Equipment, Traction, Powered |
Applicant | AKRON MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ITH |
CFR Regulation Number | 890.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-14 |
Decision Date | 1984-01-13 |