The following data is part of a premarket notification filed by Medicon, E.g. with the FDA for Medicon Vipair High Speed System.
| Device ID | K042974 |
| 510k Number | K042974 |
| Device Name: | MEDICON VIPAIR HIGH SPEED SYSTEM |
| Classification | Motor, Drill, Pneumatic |
| Applicant | MEDICON, E.G. GAENSAECKER 15 Tuttlingen, DE D-78532 |
| Contact | Joachim Schmid |
| Correspondent | Joachim Schmid MEDICON, E.G. GAENSAECKER 15 Tuttlingen, DE D-78532 |
| Product Code | HBB |
| CFR Regulation Number | 882.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-28 |
| Decision Date | 2005-01-13 |
| Summary: | summary |