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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 K935317
Device Name ALPHA TALKER
Applicant
Prentke Romich Co.
1022 Heyl Rd.
Wooster,  OH  44691
Applicant Contact DAVE HERSHBERGER
Correspondent
Prentke Romich Co.
1022 Heyl Rd.
Wooster,  OH  44691
Correspondent Contact DAVE HERSHBERGER
Regulation Number890.3860
Classification Product Code
ITI  
Date Received11/04/1993
Decision Date 03/28/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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