SIMS CHAIR

System, Isokinetic Testing And Evaluation

TWIN CITY SURGICAL, INC.

The following data is part of a premarket notification filed by Twin City Surgical, Inc. with the FDA for Sims Chair.

Pre-market Notification Details

Device IDK861632
510k NumberK861632
Device Name:SIMS CHAIR
ClassificationSystem, Isokinetic Testing And Evaluation
Applicant TWIN CITY SURGICAL, INC. 2800 N.FAIRVIEW AVE. St. Paul,  MN  55113
ContactWayne O Duescher
CorrespondentWayne O Duescher
TWIN CITY SURGICAL, INC. 2800 N.FAIRVIEW AVE. St. Paul,  MN  55113
Product CodeIKK  
CFR Regulation Number890.1925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-29
Decision Date1986-05-27

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