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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Special Grade
510(k) Number K861943
Device Name PCI CUSTOM DESIGN SERIES
Applicant
Poston & Cole Intl.
2550 Ninth St., Suite 111
Berkeley,  CA  94710
Applicant Contact RUDY BAHR
Correspondent
Poston & Cole Intl.
2550 Ninth St., Suite 111
Berkeley,  CA  94710
Correspondent Contact RUDY BAHR
Regulation Number890.3880
Classification Product Code
IQC  
Date Received05/20/1986
Decision Date 05/30/1986
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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