The following data is part of a premarket notification filed by Leibinger & Fischer Ltd. with the FDA for Stp Complete Module Set.
Device ID | K892425 |
510k Number | K892425 |
Device Name: | STP COMPLETE MODULE SET |
Classification | Accelerator, Linear, Medical |
Applicant | LEIBINGER & FISCHER LTD. 4500 TRAMMELL CROW CENTER 2001 ROSS AVENUE Dallas, TX 75201 |
Contact | & Mckenzie |
Correspondent | & Mckenzie LEIBINGER & FISCHER LTD. 4500 TRAMMELL CROW CENTER 2001 ROSS AVENUE Dallas, TX 75201 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-10 |
Decision Date | 1990-03-23 |