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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 K844574
Device Name WHEELCHAIRS
Applicant
Medicon, Inc.
143 New Canaan Ave.
Norwalk,  CT  06850
Applicant Contact JAMES C NICHOLAS
Correspondent
Medicon, Inc.
143 New Canaan Ave.
Norwalk,  CT  06850
Correspondent Contact JAMES C NICHOLAS
Regulation Number890.3850
Classification Product Code
IOR  
Date Received11/23/1984
Decision Date 02/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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