The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Minor Surgery Light.
Device ID | K810207 |
510k Number | K810207 |
Device Name: | MINOR SURGERY LIGHT |
Classification | Lamp, Surgical, Incandescent |
Applicant | CAVITRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GBC |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-26 |
Decision Date | 1981-02-13 |