The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Laser, Co2 Surgical.
| Device ID | K782054 |
| 510k Number | K782054 |
| Device Name: | LASER, CO2 SURGICAL |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | CAVITRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-07 |
| Decision Date | 1979-01-17 |