The following data is part of a premarket notification filed by Satelec with the FDA for Piezoelectric System.
| Device ID | K100410 |
| 510k Number | K100410 |
| Device Name: | PIEZOELECTRIC SYSTEM |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| Applicant | SATELEC 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Contact | Rick Rosati |
| Correspondent | Rick Rosati SATELEC 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Product Code | JDX |
| Subsequent Product Code | DZI |
| Subsequent Product Code | ERL |
| Subsequent Product Code | HBE |
| Subsequent Product Code | HWE |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03609820877358 | K100410 | 000 |
| 03609820877037 | K100410 | 000 |
| 03609820877044 | K100410 | 000 |
| 03609820877068 | K100410 | 000 |
| 03609820877075 | K100410 | 000 |
| 03609820877082 | K100410 | 000 |
| 03609820877099 | K100410 | 000 |
| 03609820877112 | K100410 | 000 |
| 03609820877129 | K100410 | 000 |
| 03609820877136 | K100410 | 000 |
| 03609820877150 | K100410 | 000 |
| 03609820877228 | K100410 | 000 |
| 03609820877242 | K100410 | 000 |
| 03609820877303 | K100410 | 000 |
| 03609820877310 | K100410 | 000 |
| 03609820877327 | K100410 | 000 |
| 03609820877341 | K100410 | 000 |
| 03609820877020 | K100410 | 000 |