The following data is part of a premarket notification filed by Satelec-acteon Group with the FDA for Scanwave Pen (with Light Gray Cord), Scanwave Pen (with Medium Gray Cord), Scanwave Pen (with Dark Gray Cord), Scanwave.
| Device ID | K131906 |
| 510k Number | K131906 |
| Device Name: | SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | SATELEC-ACTEON GROUP 124 GAITHER DRIVE , SUITE 140 Mt Laurel, NJ 08054 |
| Contact | Rick Rosati |
| Correspondent | Rick Rosati SATELEC-ACTEON GROUP 124 GAITHER DRIVE , SUITE 140 Mt Laurel, NJ 08054 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-26 |
| Decision Date | 2014-04-11 |
| Summary: | summary |