The following data is part of a premarket notification filed by Satelec with the FDA for Cocoon Hygienist.
| Device ID | K040529 |
| 510k Number | K040529 |
| Device Name: | COCOON HYGIENIST |
| Classification | Unit, Operative Dental |
| Applicant | SATELEC 70 WALNUT ST. Wellesley, MA 02481 |
| Contact | Jean-luc Boulnois |
| Correspondent | Jean-luc Boulnois SATELEC 70 WALNUT ST. Wellesley, MA 02481 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-01 |
| Decision Date | 2004-08-19 |
| Summary: | summary |