The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Endobeam Holmium Laser Fibers.
| Device ID | K120926 |
| 510k Number | K120926 |
| Device Name: | ENDOBEAM HOLMIUM LASER FIBERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD Covington, GA 30209 |
| Contact | Terri Morris |
| Correspondent | Terri Morris C.R. BARD, INC. 8195 INDUSTRIAL BLVD Covington, GA 30209 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-27 |
| Decision Date | 2012-07-27 |
| Summary: | summary |