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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Environmental Control, Powered
510(k) Number K944345
Device Name BEDSIDE BUTLER
Applicant
Trac Medical, Inc.
4106 Wake Forest Rd.
Raliegh,  NC  27609
Applicant Contact TERRY N WILLIAMS
Correspondent
Trac Medical, Inc.
4106 Wake Forest Rd.
Raliegh,  NC  27609
Correspondent Contact TERRY N WILLIAMS
Regulation Number890.3725
Classification Product Code
IQA  
Date Received09/06/1994
Decision Date 10/17/1994
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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