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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K001923
Device Name REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800
Applicant
GENDRON, INC.
400 EAST LUGBILL RD.
P.O. BOX 0197
ARCHBOLD,  OH  43502 -0197
Applicant Contact FREDERIC W STROBEL
Correspondent
GENDRON, INC.
400 EAST LUGBILL RD.
P.O. BOX 0197
ARCHBOLD,  OH  43502 -0197
Correspondent Contact FREDERIC W STROBEL
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/23/2000
Decision Date 08/25/2000
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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