DIDECO-SHILEY WASTE COLLECTION BAG

Apparatus, Autotransfusion

SHILEY, INC.

The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Dideco-shiley Waste Collection Bag.

Pre-market Notification Details

Device IDK872158
510k NumberK872158
Device Name:DIDECO-SHILEY WASTE COLLECTION BAG
ClassificationApparatus, Autotransfusion
Applicant SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92714
ContactGanz Pobuda
CorrespondentGanz Pobuda
SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92714
Product CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-04
Decision Date1987-07-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
38033178110830 K872158 000
38033178110151 K872158 000
38033178105447 K872158 000
38033178105430 K872158 000

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