The following data is part of a premarket notification filed by Applied Medical Technologies with the FDA for Contrast Background Material.
| Device ID | K895681 |
| 510k Number | K895681 |
| Device Name: | CONTRAST BACKGROUND MATERIAL |
| Classification | Needle, Suturing, Disposable |
| Applicant | APPLIED MEDICAL TECHNOLOGIES 6100 WEST CREEK RD. SUITE 25 Independence, OH 44131 |
| Contact | Dean Secrest |
| Correspondent | Dean Secrest APPLIED MEDICAL TECHNOLOGIES 6100 WEST CREEK RD. SUITE 25 Independence, OH 44131 |
| Product Code | GAB |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-21 |
| Decision Date | 1989-10-24 |