The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Implantable Clip For General Surgery.
| Device ID | K993135 |
| 510k Number | K993135 |
| Device Name: | IMPLANTABLE CLIP FOR GENERAL SURGERY |
| Classification | Clip, Implantable |
| Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Contact | Anil Bhalani |
| Correspondent | Anil Bhalani APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-20 |
| Decision Date | 1999-12-01 |
| Summary: | summary |