MED-TEC KNEE CRUTCH

Accelerator, Linear, Medical

MEDTEC, INC.

The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Med-tec Knee Crutch.

Pre-market Notification Details

Device IDK951717
510k NumberK951717
Device Name:MED-TEC KNEE CRUTCH
ClassificationAccelerator, Linear, Medical
Applicant MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City,  IA  51041
ContactDonald Riibe
CorrespondentDonald Riibe
MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City,  IA  51041
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-13
Decision Date1995-06-28

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