The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Intervent Allergen Exclusion Technology, Intervent Bedding System, Intervent Mattress Interliner, Interview Pillow.
| Device ID | K940327 |
| 510k Number | K940327 |
| Device Name: | INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW |
| Classification | Cover, Mattress (medical Purposes) |
| Applicant | W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. DOCK-A P.O. BOX 900 Flagstaff, AR 86002 |
| Contact | Dawn Lopez |
| Correspondent | Dawn Lopez W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. DOCK-A P.O. BOX 900 Flagstaff, AR 86002 |
| Product Code | FMW |
| CFR Regulation Number | 880.6190 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-24 |
| Decision Date | 1994-02-25 |