The following data is part of a premarket notification filed by Good-lite Co. with the FDA for Surgical Headlight.
Device ID | K842515 |
510k Number | K842515 |
Device Name: | SURGICAL HEADLIGHT |
Classification | Light, Surgical Headlight |
Applicant | GOOD-LITE CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBA |
CFR Regulation Number | 872.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-12 |
Decision Date | 1984-08-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SURGICAL HEADLIGHT 98617672 not registered Live/Pending |
simon gonzalez 2024-06-25 |