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510(k) Premarket Notification

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Device Classification Name wheelchair, mechanical
510(k) NumberK935398
Model 1000 SERIES
Device NameTRACER SERIES MANUAL WHEELCHAIRS
Applicant
INVACARE CORP.
899 cleveland st.
p.o. box 4028
elyria,  OH  44036
Contactedward a kroll
Regulation Number890.3850
Classification Product Code
IOR  
Date Received11/09/1993
Decision Date 03/01/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
Statement/Summary/Purged Status Summary only
Type Traditional
Reviewed by Third Party No
Expedited Review
 
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