The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Mediseal Suction Canister.
| Device ID | K895427 |
| 510k Number | K895427 |
| Device Name: | MEDISEAL SUCTION CANISTER |
| Classification | Suction Control, Intracardiac, Cardiopulmonary Bypass |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | DWD |
| CFR Regulation Number | 870.4430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-05 |
| Decision Date | 1990-01-19 |