The following data is part of a premarket notification filed by Kavo America Corporation with the FDA for Rondoflex Plus 360.
| Device ID | K042872 |
| 510k Number | K042872 |
| Device Name: | RONDOFLEX PLUS 360 |
| Classification | Airbrush |
| Applicant | KAVO AMERICA CORPORATION PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm KAVO AMERICA CORPORATION PO BOX 7007 Deerfield, IL 60015 |
| Product Code | KOJ |
| CFR Regulation Number | 872.6080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-18 |
| Decision Date | 2004-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV100221790 | K042872 | 000 |
| EKAV100059570 | K042872 | 000 |
| EKAV100059560 | K042872 | 000 |
| EKAV100059550 | K042872 | 000 |
| EKAV100059540 | K042872 | 000 |