The following data is part of a premarket notification filed by Laserguide with the FDA for Surgi-light Disposable System For Pulmonology Use.
| Device ID | K875104 |
| 510k Number | K875104 |
| Device Name: | SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE |
| Classification | Laser, Neodymium:yag, Pulmonary Surgery |
| Applicant | LASERGUIDE 51 SANTA FELICIA DR. Santa Barbara, CA 93117 |
| Contact | Robert C Michaels |
| Correspondent | Robert C Michaels LASERGUIDE 51 SANTA FELICIA DR. Santa Barbara, CA 93117 |
| Product Code | LLO |
| CFR Regulation Number | 874.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-18 |
| Decision Date | 1988-02-02 |