The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System.
| Device ID | K963850 |
| 510k Number | K963850 |
| Device Name: | PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | DEKNATEL, INC. 600 AIRPORT ROAD, P.O. BOX 2980 Fall River, MA 02722 -2980 |
| Contact | Dean E Ciporkin |
| Correspondent | Dean E Ciporkin DEKNATEL, INC. 600 AIRPORT ROAD, P.O. BOX 2980 Fall River, MA 02722 -2980 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-25 |
| Decision Date | 1997-04-22 |
| Summary: | summary |