The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Stockert Shiley Dual Pressure Control Module Xr.
Device ID | K900797 |
510k Number | K900797 |
Device Name: | STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR |
Classification | Gauge, Pressure, Coronary, Cardiopulmonary Bypass |
Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
Contact | Abati, Phd |
Correspondent | Abati, Phd SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
Product Code | DXS |
CFR Regulation Number | 870.4310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-20 |
Decision Date | 1990-05-10 |