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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 K925146
Device Name FOLDING, WHEELCHAIR
Applicant
Brownstone Trading Co.
714 E. University
El Paso,  TX  79902
Applicant Contact PAT O'ROURKE
Correspondent
Brownstone Trading Co.
714 E. University
El Paso,  TX  79902
Correspondent Contact PAT O'ROURKE
Regulation Number890.3850
Classification Product Code
IOR  
Date Received10/13/1992
Decision Date 02/12/1993
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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