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 |