The following data is part of a premarket notification filed by Stanco Medical, Inc. with the FDA for Disp. Tougy-borst Type Adaptor W/port.
| Device ID | K802328 |
| 510k Number | K802328 |
| Device Name: | DISP. TOUGY-BORST TYPE ADAPTOR W/PORT |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | STANCO MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-23 |
| Decision Date | 1980-10-10 |