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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Pressure Measurement, Intermittent
510(k) Number K831800
Device Name TEXAS INTERFACE PRESSURE EVALUATOR-TIPE
Applicant
Tee-Kay Applied Technology
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Tee-Kay Applied Technology
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.1600
Classification Product Code
JFC  
Date Received05/23/1983
Decision Date 08/16/1983
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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