The following data is part of a premarket notification filed by Vat-tech, Inc. with the FDA for Vax-t Pelvic Traction Belt.
Device ID | K894435 |
510k Number | K894435 |
Device Name: | VAX-T PELVIC TRACTION BELT |
Classification | Equipment, Traction, Powered |
Applicant | VAT-TECH, INC. 208 EVANS AVENUE Toronto Ont. M8z 1j7, CA |
Contact | J Hopkinson |
Correspondent | J Hopkinson VAT-TECH, INC. 208 EVANS AVENUE Toronto Ont. M8z 1j7, CA |
Product Code | ITH |
CFR Regulation Number | 890.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-20 |
Decision Date | 1989-08-03 |