The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Modification To Implantable Clip.
| Device ID | K011236 |
| 510k Number | K011236 |
| Device Name: | MODIFICATION TO IMPLANTABLE CLIP |
| Classification | Clip, Implantable |
| Applicant | APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Anil Bhalani |
| Correspondent | Anil Bhalani APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-23 |
| Decision Date | 2001-05-14 |