The following data is part of a premarket notification filed by Dc International, Llc with the FDA for Dc 7.
| Device ID | K131839 |
| 510k Number | K131839 |
| Device Name: | DC 7 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DC INTERNATIONAL, LLC 624 CYPRESS GREEN CIR. Wellington, FL 33414 |
| Contact | David Boegler |
| Correspondent | David Boegler DC INTERNATIONAL, LLC 624 CYPRESS GREEN CIR. Wellington, FL 33414 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-21 |
| Decision Date | 2013-11-07 |
| Summary: | summary |