The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Mcas (modular Clip Applier System).
| Device ID | K983744 |
| 510k Number | K983744 |
| Device Name: | MCAS (MODULAR CLIP APPLIER SYSTEM) |
| Classification | Clip, Vascular |
| Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Contact | Howard V Rowe |
| Correspondent | Howard V Rowe APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Product Code | DSS |
| CFR Regulation Number | 870.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-23 |
| Decision Date | 1999-01-21 |
| Summary: | summary |