The following data is part of a premarket notification filed by Quantel Medical with the FDA for Supra Scan Delivery System.
| Device ID | K100678 |
| 510k Number | K100678 |
| Device Name: | SUPRA SCAN DELIVERY SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | QUANTEL MEDICAL 21 RUE NEWTON; ZI LE BREZET Clermont Ferrand, FR 63039 |
| Contact | Patrick Quero |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-03-10 |
| Decision Date | 2010-07-21 |
| Summary: | summary |