The following data is part of a premarket notification filed by Laserscope with the FDA for Ktp/532 Laser For Ob-gyn Use.
Device ID | K874837 |
510k Number | K874837 |
Device Name: | KTP/532 LASER FOR OB-GYN USE |
Classification | Laser, Surgical, Gynecologic |
Applicant | LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
Contact | Richard P Rudy |
Correspondent | Richard P Rudy LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
Product Code | HHR |
CFR Regulation Number | 884.4550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-24 |
Decision Date | 1988-03-14 |