The following data is part of a premarket notification filed by Image Stream Medical, Inc. with the FDA for Mainstream Or Surgical Light Control (mslc).
| Device ID | K081698 |
| 510k Number | K081698 |
| Device Name: | MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) |
| Classification | Light, Surgical, Accessories |
| Applicant | IMAGE STREAM MEDICAL, INC. 11 MYSTIC AVE. Winchester, MA 01890 -2920 |
| Contact | Chas Burr |
| Correspondent | Chas Burr IMAGE STREAM MEDICAL, INC. 11 MYSTIC AVE. Winchester, MA 01890 -2920 |
| Product Code | FTA |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-17 |
| Decision Date | 2008-07-30 |
| Summary: | summary |