CONCEPT SWITCHING STICK

Accessories, Catheter

CONCEPT, INC.

The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept Switching Stick.

Pre-market Notification Details

Device IDK873009
510k NumberK873009
Device Name:CONCEPT SWITCHING STICK
ClassificationAccessories, Catheter
Applicant CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater,  FL  33546
ContactLori Colvin
CorrespondentLori Colvin
CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater,  FL  33546
Product CodeKGZ  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-04
Decision Date1987-08-17

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