The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Deknatel Dsp Pleur-evac Autotransfusion Blood Recovery Bag.
| Device ID | K964070 |
| 510k Number | K964070 |
| Device Name: | DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG |
| Classification | Apparatus, Autotransfusion |
| Applicant | DEKNATEL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Diane E Minear |
| Correspondent | Diane E Minear DEKNATEL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-10 |
| Decision Date | 1996-12-31 |
| Summary: | summary |