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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 K003862
Device Name MADA WHEELCHAIRS
Applicant
Mada Medical Products, Inc.
625 Washington Ave.
Carlstadt,  NJ  07072
Applicant Contact JEFFREY W ADAM
Correspondent
Mada Medical Products, Inc.
625 Washington Ave.
Carlstadt,  NJ  07072
Correspondent Contact JEFFREY W ADAM
Regulation Number890.3850
Classification Product Code
IOR  
Date Received12/13/2000
Decision Date 01/12/2001
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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