The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Slt Contact Laser System Endophotocoagulation.
Device ID | K882441 |
510k Number | K882441 |
Device Name: | SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION |
Classification | Photocoagulator And Accessories |
Applicant | SURGICAL LASER TECHNOLOGIES, INC. ONE GREAT VALLEY PKWY. Malvern, PA 19355 |
Contact | Gifford, R.n. |
Correspondent | Gifford, R.n. SURGICAL LASER TECHNOLOGIES, INC. ONE GREAT VALLEY PKWY. Malvern, PA 19355 |
Product Code | HQB |
CFR Regulation Number | 886.4690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-14 |
Decision Date | 1988-09-26 |