MED-TEC HAND GRIP

Table, Radiographic, Stationary Top

MEDTEC, INC.

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

Pre-market Notification Details

Device IDK954225
510k NumberK954225
Device Name:MED-TEC HAND GRIP
ClassificationTable, Radiographic, Stationary Top
Applicant MEDTEC, INC. P.O. BOX 487 1401 8TH STREET SOUTH EAST Orange City,  IA  51041 -0487
ContactDonald F Riibe
CorrespondentDonald F Riibe
MEDTEC, INC. P.O. BOX 487 1401 8TH STREET SOUTH EAST Orange City,  IA  51041 -0487
Product CodeIXQ  
CFR Regulation Number892.1980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-11
Decision Date1995-11-14

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