The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Modified Stockert-shiley Caps Multi. Roller Pump.
| Device ID | K890904 |
| 510k Number | K890904 |
| Device Name: | MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Merritt M Girgis |
| Correspondent | Merritt M Girgis SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | DWB |
| CFR Regulation Number | 870.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-10 |
| Decision Date | 1989-04-12 |