The following data is part of a premarket notification filed by Laserscope with the FDA for Ktp/532 Surgical Laser.
Device ID | K884029 |
510k Number | K884029 |
Device Name: | KTP/532 SURGICAL LASER |
Classification | Powered Laser Surgical Instrument |
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 | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-23 |
Decision Date | 1988-11-25 |