ACUMED FLEXIBLE CANNULA

Arthroscope

ACUMED, INC.

The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Acumed Flexible Cannula.

Pre-market Notification Details

Device IDK932099
510k NumberK932099
Device Name:ACUMED FLEXIBLE CANNULA
ClassificationArthroscope
Applicant ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
ContactGene Conrad
CorrespondentGene Conrad
ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-03
Decision Date1994-06-28

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