The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Orth-evac(tm) Suction Hand Bulb Model No. 01-150.
| Device ID | K910211 |
| 510k Number | K910211 |
| Device Name: | ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150 |
| Classification | Apparatus, Autotransfusion |
| Applicant | DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Contact | Michael Santalucia |
| Correspondent | Michael Santalucia 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 | 1991-01-15 |
| Decision Date | 1991-04-03 |