The following data is part of a premarket notification filed by Vanguard Medical Concepts, Inc. with the FDA for Ami Reprocessed Multiple Clip Appliers.
| Device ID | K032980 |
| 510k Number | K032980 |
| Device Name: | AMI REPROCESSED MULTIPLE CLIP APPLIERS |
| Classification | Clip, Implantable |
| Applicant | VANGUARD MEDICAL CONCEPTS, INC. 3706 76TH STREET Lubbock, TX 79423 |
| Contact | Mark Aldana |
| Correspondent | Mark Aldana VANGUARD MEDICAL CONCEPTS, INC. 3706 76TH STREET Lubbock, TX 79423 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-24 |
| Decision Date | 2003-12-18 |
| Summary: | summary |