The following data is part of a premarket notification filed by Pfizer Hospital Products Group, Inc. with the FDA for Pleur-evac Plus Contin. Reinfus. & Autoinfus. Syst.
| Device ID | K911656 |
| 510k Number | K911656 |
| Device Name: | PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYST |
| Classification | Apparatus, Autotransfusion |
| Applicant | PFIZER HOSPITAL PRODUCTS GROUP, INC. 600 AIRPORT RD. Fall River, MA 02722 |
| Contact | Micheal Santalucia |
| Correspondent | Micheal Santalucia PFIZER HOSPITAL PRODUCTS GROUP, INC. 600 AIRPORT RD. Fall River, MA 02722 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-12 |
| Decision Date | 1991-08-13 |