SCHNEIDER-SHILEY INFLATION SYRINGES

Syringe, Balloon Inflation

SHILEY, INC.

The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Schneider-shiley Inflation Syringes.

Pre-market Notification Details

Device IDK861607
510k NumberK861607
Device Name:SCHNEIDER-SHILEY INFLATION SYRINGES
ClassificationSyringe, Balloon Inflation
Applicant SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92714
ContactMorton Barak
CorrespondentMorton Barak
SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92714
Product CodeMAV  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-29
Decision Date1986-06-09

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