The following data is part of a premarket notification filed by Satelec with the FDA for I-surge.
| Device ID | K071965 |
| 510k Number | K071965 |
| Device Name: | I-SURGE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | SATELEC 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Contact | Steve Salesky |
| Correspondent | Steve Salesky SATELEC 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-16 |
| Decision Date | 2007-09-10 |
| Summary: | summary |