The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Slt Contact Laser System Nd:yag Medical Laser Syst.
Device ID | K903936 |
510k Number | K903936 |
Device Name: | SLT CONTACT LASER SYSTEM ND:YAG MEDICAL LASER SYST |
Classification | Powered Laser Surgical Instrument |
Applicant | SURGICAL LASER TECHNOLOGIES, INC. ONE GREAT VALLEY PKWY. Malvern, PA 19355 |
Contact | Cynthia A Gifford |
Correspondent | Cynthia A Gifford SURGICAL LASER TECHNOLOGIES, INC. ONE GREAT VALLEY PKWY. Malvern, PA 19355 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-27 |
Decision Date | 1990-10-26 |