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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K021145
Device Name ACCOMMODATOR WHEELCHAIR, MODEL #2000X
Applicant
Marken International, Inc.
851 Bridger St.
Suite 1
Bozeman,  MT  59715
Applicant Contact STEVE RIFFEL
Correspondent
Marken International, Inc.
851 Bridger St.
Suite 1
Bozeman,  MT  59715
Correspondent Contact STEVE RIFFEL
Regulation Number890.3850
Classification Product Code
IOR  
Date Received04/09/2002
Decision Date 05/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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