The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Orth-evac Tm.
| Device ID | K900325 |
| 510k Number | K900325 |
| Device Name: | ORTH-EVAC TM |
| Classification | Apparatus, Autotransfusion |
| Applicant | DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Contact | Harry Savard |
| Correspondent | Harry Savard DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-23 |
| Decision Date | 1990-07-03 |