The following data is part of a premarket notification filed by Laserscope with the FDA for Ktp/532 Laser.
Device ID | K873330 |
510k Number | K873330 |
Device Name: | KTP/532 LASER |
Classification | Laser For Gastro-urology Use |
Applicant | LASERSCOPE 3350 SCOTT BLVD., BLDG.30 Santa Clara, CA 95051 |
Contact | Richard P Rudy |
Correspondent | Richard P Rudy LASERSCOPE 3350 SCOTT BLVD., BLDG.30 Santa Clara, CA 95051 |
Product Code | LNK |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-19 |
Decision Date | 1987-11-18 |