The following data is part of a premarket notification filed by Velopex International, Inc. with the FDA for Velopex Aquacut Fluid Abrasion Unit.
| Device ID | K024105 |
| 510k Number | K024105 |
| Device Name: | VELOPEX AQUACUT FLUID ABRASION UNIT |
| Classification | Airbrush |
| Applicant | VELOPEX INTERNATIONAL, INC. 105 EAST 17TH ST. St. Cloud, FL 34769 |
| Contact | Tony Urella |
| Correspondent | Tony Urella VELOPEX INTERNATIONAL, INC. 105 EAST 17TH ST. St. Cloud, FL 34769 |
| Product Code | KOJ |
| CFR Regulation Number | 872.6080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-13 |
| Decision Date | 2003-10-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060209580012 | K024105 | 000 |