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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 K932927
Device Name SRX COMP ULTRALIGHT WHEELCHAIR
Applicant
Medical Composite Technology, Inc.
333 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606
Applicant Contact JOHN F LEMKER
Correspondent
Medical Composite Technology, Inc.
333 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606
Correspondent Contact JOHN F LEMKER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received06/15/1993
Decision Date 07/22/1993
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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