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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Garment, Protective, For Incontinence
510(k) Number K843869
Device Name TRANQUILITY
Applicant
Principle Business Ent.
Pine Lake Industrial Pk.
Dunbridge,  OH  43414
Applicant Contact ROBERT L TURAIN
Correspondent
Principle Business Ent.
Pine Lake Industrial Pk.
Dunbridge,  OH  43414
Correspondent Contact ROBERT L TURAIN
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received10/02/1984
Decision Date 11/16/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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