The following data is part of a premarket notification filed by Huot Instruments, Llc with the FDA for Startrol Led Lighting Systems (x=# Of Pods, Y=# Of Leds, N=to Mounting Style) Model X X Y -n-s-w. X=number Of Light Pods.
| Device ID | K100702 |
| 510k Number | K100702 |
| Device Name: | STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | HUOT INSTRUMENTS, LLC N50 W13740 OVERVIEW DR. SUITE A Menomonee Falls, WI 53051 |
| Contact | Anne Ward |
| Correspondent | Anne Ward HUOT INSTRUMENTS, LLC N50 W13740 OVERVIEW DR. SUITE A Menomonee Falls, WI 53051 |
| Product Code | FSY |
| Subsequent Product Code | FSS |
| Subsequent Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-12 |
| Decision Date | 2010-07-20 |
| Summary: | summary |