The following data is part of a premarket notification filed by Image Stream Medical, Inc. with the FDA for Easysuite Surgical Light Control (eslc).
| Device ID | K102791 |
| 510k Number | K102791 |
| Device Name: | EASYSUITE SURGICAL LIGHT CONTROL (ESLC) |
| Classification | Light, Surgical, Accessories |
| Applicant | IMAGE STREAM MEDICAL, INC. ONE MONARCH DR. Littleton, MA 01460 |
| Contact | Beth Cyr |
| Correspondent | Beth Cyr IMAGE STREAM MEDICAL, INC. ONE MONARCH DR. Littleton, MA 01460 |
| Product Code | FTA |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-27 |
| Decision Date | 2010-11-23 |
| Summary: | summary |