The following data is part of a premarket notification filed by Tlelflex Medical, Inc. with the FDA for Pleur-evac Sahara Plus Continous Reinfusion Autotransfusion System.
| Device ID | K120953 |
| 510k Number | K120953 |
| Device Name: | PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | TLELFLEX MEDICAL, INC. 2917 Weck Drive Research Triangle Park, NC 27709 |
| Contact | Lorraine Delong |
| Correspondent | Lorraine Delong TLELFLEX MEDICAL, INC. 2917 Weck Drive Research Triangle Park, NC 27709 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-30 |
| Decision Date | 2012-12-10 |
| Summary: | summary |