510(k) K940327

INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW by W. L. Gore & Associates, Inc. — Product Code FMW

K940327 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW". The FDA issued a decision of Substantially Equivalent on February 25, 1994. The device falls under product code FMW (Cover, Mattress (Medical Purposes)), a Class I device regulated under 21 CFR 880.6190. W. L. Gore & Associates, Inc. has at least 10 other 510(k) clearances on record.