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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 K973418
Device Name UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)
Applicant
ASSEMBLY REQUIRED DIST., INC.
3 CRABAPPLE LN.
COMMACK,  NY  11725 -2403
Applicant Contact ROBERT J MURPHY
Correspondent
ASSEMBLY REQUIRED DIST., INC.
3 CRABAPPLE LN.
COMMACK,  NY  11725 -2403
Correspondent Contact ROBERT J MURPHY
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/10/1997
Decision Date 10/09/1997
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
Predetermined Change
Control Plan Authorized		 No
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