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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 K993963
Device Name SIGMA MANUAL WHEELCHAIR
Applicant
Sigma Distribution & Supply, Inc.
701 W. Harvard St.
Glendale,  CA  91204
Applicant Contact ARTHUR KESHISHYAN
Correspondent
Sigma Distribution & Supply, Inc.
701 W. Harvard St.
Glendale,  CA  91204
Correspondent Contact ARTHUR KESHISHYAN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received11/22/1999
Decision Date 01/13/2000
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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