The following data is part of a premarket notification filed by Mattioli Engineering Corp. with the FDA for Mattioli Pulse Two/three Plus Family.
| Device ID | K100053 |
| 510k Number | K100053 |
| Device Name: | MATTIOLI PULSE TWO/THREE PLUS FAMILY |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | MATTIOLI ENGINEERING CORP. 8300 GREENSBORO DR. SUITE 800 Mclean, VA 22102 |
| Contact | Gianfranco Bernabei |
| Correspondent | Gianfranco Bernabei MATTIOLI ENGINEERING CORP. 8300 GREENSBORO DR. SUITE 800 Mclean, VA 22102 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-08 |
| Decision Date | 2010-03-10 |
| Summary: | summary |