The following data is part of a premarket notification filed by Laser Spectrum, Inc. with the FDA for Accessory Set For Co2 Laser Bronchoscopy Instrumen.
| Device ID | K844765 |
| 510k Number | K844765 |
| Device Name: | ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN |
| Classification | Saw, Surgical, Ent (electric Or Pneumatic) |
| Applicant | LASER SPECTRUM, INC. 100 SOUTH WACKER DRIVE Chicago , IL 60606 - |
| Contact | Robert E Browne |
| Correspondent | Robert E Browne LASER SPECTRUM, INC. 100 SOUTH WACKER DRIVE Chicago , IL 60606 - |
| Product Code | EWQ |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-07 |
| Decision Date | 1985-04-08 |