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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Communication, Powered
510(k) Number K925527
Device Name LIGHT TALKER
Applicant
Prentke Romich Co.
1022 Heyl Rd.
Wooster,  OH  44691
Applicant Contact MICHAEL MOLTER
Correspondent
Prentke Romich Co.
1022 Heyl Rd.
Wooster,  OH  44691
Correspondent Contact MICHAEL MOLTER
Regulation Number890.3710
Classification Product Code
ILQ  
Date Received11/02/1992
Decision Date 03/22/1993
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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