MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP

Pump, Blood, Cardiopulmonary Bypass, Roller Type

SHILEY, INC.

The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Modified Stockert-shiley Caps Multi. Roller Pump.

Pre-market Notification Details

Device IDK890904
510k NumberK890904
Device Name:MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP
ClassificationPump, Blood, Cardiopulmonary Bypass, Roller Type
Applicant SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92714
ContactMerritt M Girgis
CorrespondentMerritt M Girgis
SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92714
Product CodeDWB  
CFR Regulation Number870.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-10
Decision Date1989-04-12

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