The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Dideco-shiley Blood Separation Wash Bowl.
Device ID | K872160 |
510k Number | K872160 |
Device Name: | DIDECO-SHILEY BLOOD SEPARATION WASH BOWL |
Classification | Apparatus, Autotransfusion |
Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
Contact | Ganz Pobuda |
Correspondent | Ganz Pobuda SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
Product Code | CAC |
CFR Regulation Number | 868.5830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-04 |
Decision Date | 1987-07-24 |