The following data is part of a premarket notification filed by Pfizer Laser Systems with the FDA for 35 Watt Surgical Carbon Dioxide Laser System.
| Device ID | K896049 |
| 510k Number | K896049 |
| Device Name: | 35 WATT SURGICAL CARBON DIOXIDE LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PFIZER LASER SYSTEMS 3 MORGAN Irvine, CA 92718 |
| Contact | Cozean, Phd |
| Correspondent | Cozean, Phd PFIZER LASER SYSTEMS 3 MORGAN Irvine, CA 92718 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-18 |
| Decision Date | 1990-01-11 |