K940327 is an FDA 510(k) clearance for the INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW. This device is classified as a Cover, Mattress (medical Purposes) (Class I — General Controls, product code FMW).
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on February 25, 1994, 32 days after receiving the submission on January 24, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6190.
| 510(k) Number | K940327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 1994 |
| Decision Date | February 25, 1994 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMW — Cover, Mattress (medical Purposes) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.6190 |