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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 K930044
Device Name COMFORT KEYBOARD SYSTEM
Applicant
Health Care Keyboard Co., Inc.
N82 W15340 Appleton Ave.
Menomonee Falls,  WI  53051
Applicant Contact JEFFREY SZMANDA
Correspondent
Health Care Keyboard Co., Inc.
N82 W15340 Appleton Ave.
Menomonee Falls,  WI  53051
Correspondent Contact JEFFREY SZMANDA
Regulation Number890.3710
Classification Product Code
ILQ  
Date Received01/05/1993
Decision Date 07/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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