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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 K120077
Device Name COMED K-SERIES MANUAL WHEELCHAIR
Applicant
DANYANG COMED HEALTHCARE CO., LTD
144 research drive
hampton,  VA  23666
Applicant Contact rhonda alexander
Correspondent
DANYANG COMED HEALTHCARE CO., LTD
144 research drive
hampton,  VA  23666
Correspondent Contact rhonda alexander
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/10/2012
Decision Date 05/14/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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