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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 K894346
Device Name D88VS WHEELCHAIR POWER SYSTEM
Applicant
Damaco
20545 Plummer St.
Chatsworth,  CA  91311
Applicant Contact DAVID W BANTLE
Correspondent
Damaco
20545 Plummer St.
Chatsworth,  CA  91311
Correspondent Contact DAVID W BANTLE
Regulation Number890.3860
Classification Product Code
ITI  
Date Received07/14/1989
Decision Date 08/03/1989
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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