The following data is part of a premarket notification filed by Minnesota Laser Corp. with the FDA for Nd:yag Surgical Laser For Pulmonary Applications.
Device ID | K874254 |
510k Number | K874254 |
Device Name: | ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS |
Classification | Laser, Neodymium:yag, Pulmonary Surgery |
Applicant | MINNESOTA LASER CORP. 2452 N. PRIOR AVE. Roseville, MN 55113 |
Contact | Constance G Bundy |
Correspondent | Constance G Bundy MINNESOTA LASER CORP. 2452 N. PRIOR AVE. Roseville, MN 55113 |
Product Code | LLO |
CFR Regulation Number | 874.4500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-20 |
Decision Date | 1988-03-04 |