The following data is part of a premarket notification filed by Ceracarta Spa with the FDA for Eco Supergel.
| Device ID | K101429 |
| 510k Number | K101429 |
| Device Name: | ECO SUPERGEL |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | CERACARTA SPA P.O. BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan CERACARTA SPA P.O. BOX 560 Stillwater, MN 55082 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-21 |
| Decision Date | 2010-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057733230176 | K101429 | 000 |
| 08057733230145 | K101429 | 000 |
| 08057733230107 | K101429 | 000 |
| 08057733230084 | K101429 | 000 |