The following data is part of a premarket notification filed by Minnesota Laser Corp. with the FDA for Portalase 300 Carbon Dioxide Surg Laser Ear/nose/t.
| Device ID | K854471 |
| 510k Number | K854471 |
| Device Name: | PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T |
| Classification | Laser, Ent Microsurgical Carbon-dioxide |
| Applicant | MINNESOTA LASER CORP. 6470 RIVERVIEW TERRACE N.E. Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy MINNESOTA LASER CORP. 6470 RIVERVIEW TERRACE N.E. Minneapolis, MN 55432 |
| Product Code | EWG |
| CFR Regulation Number | 874.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-06 |
| Decision Date | 1986-02-13 |