The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Minor Surgical Light Model 180.
Device ID | K841360 |
510k Number | K841360 |
Device Name: | MINOR SURGICAL LIGHT MODEL 180 |
Classification | Lamp, Surgical |
Applicant | AMERICAN STERILIZER CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FTD |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-02 |
Decision Date | 1984-04-24 |