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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 K915108
Device Name FOLDING WHEELCHAIR
Applicant
Guardian Products Co., Inc.
12222 Sherman Way
North Hollywood,  CA  91605
Applicant Contact ALVIN R.BALL
Correspondent
Guardian Products Co., Inc.
12222 Sherman Way
North Hollywood,  CA  91605
Correspondent Contact ALVIN R.BALL
Regulation Number890.3850
Classification Product Code
IOR  
Date Received11/13/1991
Decision Date 01/13/1992
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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