The following data is part of a premarket notification filed by Apheresis Technologies, Inc. with the FDA for Ati Plasma Pump (pp-04).
| Device ID | K961137 |
| 510k Number | K961137 |
| Device Name: | ATI PLASMA PUMP (PP-04) |
| Classification | Pump, Blood, Extra-luminal |
| Applicant | APHERESIS TECHNOLOGIES, INC. 612 FLORIDA AVE. PALM HARBOR, FL 34683 |
| Contact | JOHN B CORNISH |
| Correspondent | JOHN B CORNISH APHERESIS TECHNOLOGIES, INC. 612 FLORIDA AVE. PALM HARBOR, FL 34683 |
| Product Code | FIR |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-21 |
| Decision Date | 1996-06-14 |