CONCEPT C-VAC

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

CONCEPT, INC.

The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept C-vac.

Pre-market Notification Details

Device IDK842710
510k NumberK842710
Device Name:CONCEPT C-VAC
ClassificationApparatus, Suction, Single Patient Use, Portable, Nonpowered
Applicant CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater,  FL  33546
ContactCarl A Angles
CorrespondentCarl A Angles
CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater,  FL  33546
Product CodeGCY  
CFR Regulation Number878.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-12
Decision Date1984-10-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.