The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Pleur-evac Shara Plus Model S-2150/continuous Reinfusion Autotransfusion System(s-100).
| Device ID | K963098 |
| 510k Number | K963098 |
| Device Name: | PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100) |
| Classification | Apparatus, Autotransfusion |
| Applicant | DEKNATEL, INC. 600 AIRPORT RD. Fall River, MA 02720 |
| Contact | Dean E Ciporkin |
| Correspondent | Dean E Ciporkin DEKNATEL, INC. 600 AIRPORT RD. Fall River, MA 02720 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-09 |
| Decision Date | 1996-11-08 |
| Summary: | summary |