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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 K883787
Device Name REUSABLE ADULT INCONTINENT DIAPER
Applicant
Intera Corp.
P.O. Box 25376
Chattanooga,  TN  37422 -5376
Applicant Contact LARRY ENGLISH
Correspondent
Intera Corp.
P.O. Box 25376
Chattanooga,  TN  37422 -5376
Correspondent Contact LARRY ENGLISH
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received09/07/1988
Decision Date 11/07/1988
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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