The following data is part of a premarket notification filed by Applied Medical Technologies with the FDA for Background Suction Matt.
| Device ID | K895727 |
| 510k Number | K895727 |
| Device Name: | BACKGROUND SUCTION MATT |
| Classification | Gauze/sponge, Internal, With Drug/biologic, Animal Source Material |
| 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 | GEL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-25 |
| Decision Date | 1989-10-24 |