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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 K931751
Device Name ZERO GRAVITY WHEELCHAIR
Applicant
General Components Intl., Inc.
363 W. 2720 S., Suite B
Salt Lake City,  UT  84115
Correspondent
General Components Intl., Inc.
363 W. 2720 S., Suite B
Salt Lake City,  UT  84115
Regulation Number890.3850
Classification Product Code
IOR  
Date Received04/08/1993
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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