The following data is part of a premarket notification filed by Toray Industries (america), Inc. with the FDA for Toray Vascular Prosthesis.
Device ID | K884083 |
510k Number | K884083 |
Device Name: | TORAY VASCULAR PROSTHESIS |
Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
Applicant | TORAY INDUSTRIES (AMERICA), INC. 9223 ILONA LN. Houston, TX 77025 |
Contact | Lisa S Jones |
Correspondent | Lisa S Jones TORAY INDUSTRIES (AMERICA), INC. 9223 ILONA LN. Houston, TX 77025 |
Product Code | DSY |
CFR Regulation Number | 870.3450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-27 |
Decision Date | 1989-01-12 |