The following data is part of a premarket notification filed by Sopro with the FDA for Sopro 281.
| Device ID | K103813 |
| 510k Number | K103813 |
| Device Name: | SOPRO 281 |
| Classification | Led Light Source |
| Applicant | SOPRO 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Contact | Rick Rosati |
| Correspondent | Rick Rosati SOPRO 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Product Code | NTN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-29 |
| Decision Date | 2011-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760278260014 | K103813 | 000 |
| 03760278260861 | K103813 | 000 |
| 03760278260380 | K103813 | 000 |
| 03760278260342 | K103813 | 000 |
| M430S28100021 | K103813 | 000 |
| M430S28100011 | K103813 | 000 |
| 03760278260427 | K103813 | 000 |
| 03760278260045 | K103813 | 000 |