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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 K850064
Device Name WHEELCHAIR, MECHANICAL
Applicant
Comaco, Inc.
P.O. Box 1496
Hudson,  OH  44236
Applicant Contact WILLIAM MCGRAW
Correspondent
Comaco, Inc.
P.O. Box 1496
Hudson,  OH  44236
Correspondent Contact WILLIAM MCGRAW
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/08/1985
Decision Date 04/04/1985
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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