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 |