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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 K110985
Device Name ICON ADULT MANUAL
Applicant
Icon Wheelchairs, Inc.
115 Bridge St.
Northampton,  MA  01060
Applicant Contact TOM HORTON
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number890.3850
Classification Product Code
IOR  
Date Received04/08/2011
Decision Date 05/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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