The following data is part of a premarket notification filed by Avanca Medical Devices, Inc. with the FDA for Procedur Sf Safety Syringe Device.
| Device ID | K042487 |
| 510k Number | K042487 |
| Device Name: | PROCEDUR SF SAFETY SYRINGE DEVICE |
| Classification | Syringe, Antistick |
| Applicant | AVANCA MEDICAL DEVICES, INC. 12200 ACADEMY ROAD NE # 931 Albuquerque, NM 87111 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson AVANCA MEDICAL DEVICES, INC. 12200 ACADEMY ROAD NE # 931 Albuquerque, NM 87111 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-13 |
| Decision Date | 2005-01-21 |
| Summary: | summary |