The following data is part of a premarket notification filed by Minnesota Laser Corp. with the FDA for Portalase 200 Carbon Surgical Laser System.
Device ID | K852694 |
510k Number | K852694 |
Device Name: | PORTALASE 200 CARBON SURGICAL LASER SYSTEM |
Classification | Laser, Surgical, Gynecologic |
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 | HHR |
CFR Regulation Number | 884.4550 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-26 |
Decision Date | 1985-09-30 |