SLIP-COAT(TM) CATHETERS

Catheter, Intravascular, Diagnostic

COOK, INC.

The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Slip-coat(tm) Catheters.

Pre-market Notification Details

Device IDK882796
510k NumberK882796
Device Name:SLIP-COAT(TM) CATHETERS
ClassificationCatheter, Intravascular, Diagnostic
Applicant COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington,  IN  47402
ContactApril Lavender
CorrespondentApril Lavender
COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington,  IN  47402
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-06
Decision Date1988-07-28

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