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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Components, Wheelchair
510(k) Number K933051
Device Name ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION
Applicant
General Components Intl., Inc.
363 W. 2720 S., Suite B
Salt Lake City,  UT  84115
Applicant Contact TONY M PEARCE
Correspondent
General Components Intl., Inc.
363 W. 2720 S., Suite B
Salt Lake City,  UT  84115
Correspondent Contact TONY M PEARCE
Regulation Number890.3920
Classification Product Code
KNN  
Date Received05/25/1993
Decision Date 10/12/1993
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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