The following data is part of a premarket notification filed by Advanced Biomedical Instruments with the FDA for Co2 Laser.
| Device ID | K801197 |
| 510k Number | K801197 |
| Device Name: | CO2 LASER |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | ADVANCED BIOMEDICAL INSTRUMENTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-19 |
| Decision Date | 1980-06-30 |