PCI CUSTOM DESIGN SERIES

Wheelchair, Special Grade

POSTON & COLE INTL.

The following data is part of a premarket notification filed by Poston & Cole Intl. with the FDA for Pci Custom Design Series.

Pre-market Notification Details

Device IDK861943
510k NumberK861943
Device Name:PCI CUSTOM DESIGN SERIES
ClassificationWheelchair, Special Grade
Applicant POSTON & COLE INTL. 2550 NINTH ST, STE 111 Berkeley,  CA  94710
ContactRudy Bahr
CorrespondentRudy Bahr
POSTON & COLE INTL. 2550 NINTH ST, STE 111 Berkeley,  CA  94710
Product CodeIQC  
CFR Regulation Number890.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-05-20
Decision Date1986-05-30

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