The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Slt Venous Fiber Delivery Systems, Model: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921.
Device ID | K023624 |
510k Number | K023624 |
Device Name: | SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921 |
Classification | Powered Laser Surgical Instrument |
Applicant | SURGICAL LASER TECHNOLOGIES, INC. 147 KEYSTONE DR. Montgomeryville, PA 18936 |
Contact | Davis Woodward |
Correspondent | Davis Woodward SURGICAL LASER TECHNOLOGIES, INC. 147 KEYSTONE DR. Montgomeryville, PA 18936 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-29 |
Decision Date | 2003-01-27 |
Summary: | summary |