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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 K862380
Device Name MATTRESS COVER
Applicant
Intera Corp.
P.O. Box 25376
Chattanooga,  TN  37422
Applicant Contact BRUCE LINDQUIST
Correspondent
Intera Corp.
P.O. Box 25376
Chattanooga,  TN  37422
Correspondent Contact BRUCE LINDQUIST
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received06/24/1986
Decision Date 07/28/1986
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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