SOFT TISSUE ANCHORING SET KIT

General Surgery Tray

CONCEPT, INC.

The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Soft Tissue Anchoring Set Kit.

Pre-market Notification Details

Device IDK874439
510k NumberK874439
Device Name:SOFT TISSUE ANCHORING SET KIT
ClassificationGeneral Surgery Tray
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 CodeLRO  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-28
Decision Date1987-11-20

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