The following data is part of a premarket notification filed by Respinnovation Sas with the FDA for Resin 11.
| Device ID | K121170 |
| 510k Number | K121170 |
| Device Name: | RESIN 11 |
| Classification | Percussor, Powered-electric |
| Applicant | RESPINNOVATION SAS 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden RESPINNOVATION SAS 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-17 |
| Decision Date | 2012-07-13 |
| Summary: | summary |