The following data is part of a premarket notification filed by Avanca Medical Devices, Inc. with the FDA for Procedur-10.
| Device ID | K052075 |
| 510k Number | K052075 |
| Device Name: | PROCEDUR-10 |
| Classification | Syringe, Piston |
| Applicant | AVANCA MEDICAL DEVICES, INC. 801 UNIVERSITY BLVD. SE SUITE 307 Albuquerque, NM 87106 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson AVANCA MEDICAL DEVICES, INC. 801 UNIVERSITY BLVD. SE SUITE 307 Albuquerque, NM 87106 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-01 |
| Decision Date | 2005-11-09 |
| Summary: | summary |