The following data is part of a premarket notification filed by Lasermatic, Inc. with the FDA for Model 5050 Surgilaser For Pulmonary Use.
Device ID | K871876 |
510k Number | K871876 |
Device Name: | MODEL 5050 SURGILASER FOR PULMONARY USE |
Classification | Laser, Neodymium:yag, Pulmonary Surgery |
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 | LLO |
CFR Regulation Number | 874.4500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-14 |
Decision Date | 1988-01-22 |