The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Surgical Laser Micro-tips.
Device ID | K844644 |
510k Number | K844644 |
Device Name: | SURGICAL LASER MICRO-TIPS |
Classification | Powered Laser Surgical Instrument |
Applicant | SURGICAL LASER TECHNOLOGIES, INC. 933 COLLINS RD. Villa Hills, KY 41017 |
Contact | Richard L Studer |
Correspondent | Richard L Studer SURGICAL LASER TECHNOLOGIES, INC. 933 COLLINS RD. Villa Hills, KY 41017 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-28 |
Decision Date | 1985-05-10 |