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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Mattress (Medical Purposes)
510(k) Number K940327
Device Name INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW
Applicant
W. L. Gore & Associates, Inc.
3750 W. Kiltie Ln. Dock-A
P.O. Box 900
Flagstaff,  AR  86002
Applicant Contact DAWN LOPEZ
Correspondent
W. L. Gore & Associates, Inc.
3750 W. Kiltie Ln. Dock-A
P.O. Box 900
Flagstaff,  AR  86002
Correspondent Contact DAWN LOPEZ
Regulation Number880.6190
Classification Product Code
FMW  
Date Received01/24/1994
Decision Date 02/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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