The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Sps-single Patient System.
| Device ID | K821139 |
| 510k Number | K821139 |
| Device Name: | SPS-SINGLE PATIENT SYSTEM |
| Classification | Pump, Blood, Extra-luminal |
| Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. ROYAL & ROSS ROADS King Of Prussia , PA 19406 - |
| Contact | James K Mccracken |
| Correspondent | James K Mccracken EXTRACORPOREAL MEDICAL SPECIALITIES, INC. ROYAL & ROSS ROADS King Of Prussia , PA 19406 - |
| Product Code | FIR |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-21 |
| Decision Date | 1982-05-10 |