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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 -5376
Applicant Contact BRUCE LINDQUIST
Correspondent
INTERA CORP.
P.O. BOX 25376
CHATTANOOGA,  TN  37422 -5376
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
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