Clearance Summary
INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW received FDA 510(k) clearance under submission number K940327, sponsored by W. L. Gore & Associates, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1994-02-25.
- Submission: K940327
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6190
- Decision date: 1994-02-25
Classification & Regulation
This clearance is catalogued under FDA product code FMW and 21 CFR 880.6190, within the General Hospital review panel as a Class I device.