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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 K894345
Device Name ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR
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 Number890.3850
Classification Product Code
IOR  
Date Received07/14/1989
Decision Date 07/27/1989
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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