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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 K002943
Device Name WHEELCHAIR, MECHANICAL SERIES MODEL 3100
Applicant
MADA MEDICAL PRODUCTS, INC.
625 WASHINGTON AVE.
CARLSTADT,  NJ  07072
Applicant Contact JEFFERY W ADAM
Correspondent
MADA MEDICAL PRODUCTS, INC.
625 WASHINGTON AVE.
CARLSTADT,  NJ  07072
Correspondent Contact JEFFERY W ADAM
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/21/2000
Decision Date 10/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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