The following data is part of a premarket notification filed by Lasermatic, Inc. with the FDA for Model 5050 Surgilaser For Urology Use.
Device ID | K871932 |
510k Number | K871932 |
Device Name: | MODEL 5050 SURGILASER FOR UROLOGY USE |
Classification | Laser For Gastro-urology Use |
Applicant | LASERMATIC, INC. P.O. BOX 7848 Dallas, TX 75209 |
Contact | Donald F Hults |
Correspondent | Donald F Hults LASERMATIC, INC. P.O. BOX 7848 Dallas, TX 75209 |
Product Code | LNK |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-19 |
Decision Date | 1988-03-25 |