The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for S.l.t. Contact Laser.
Device ID | K855119 |
510k Number | K855119 |
Device Name: | S.L.T. CONTACT LASER |
Classification | Laser For Gastro-urology Use |
Applicant | SURGICAL LASER TECHNOLOGIES, INC. 250 E 5TH ST. SUITE 1500 COLUMBIA PLAZA BLDG. Cincinnati, OH 45202 |
Contact | Richard Studer |
Correspondent | Richard Studer SURGICAL LASER TECHNOLOGIES, INC. 250 E 5TH ST. SUITE 1500 COLUMBIA PLAZA BLDG. Cincinnati, OH 45202 |
Product Code | LNK |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-23 |
Decision Date | 1986-02-24 |