EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
FDA 510(k) clearance K992702 · decided 1999-11-08
Clearance details
- K-number
- K992702
- Device name
- EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
- Applicant
- Allergy Direct
- Decision
- Substantially Equivalent
- Date received
- 1999-08-12
- Decision date
- 1999-11-08
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- FMW
- Device class
- 1
- Regulation number
- 880.6190
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Kansas City, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DermaTherapy Bed Linens (K152884) | Precision Fabrics Group, Inc. | 2016-06-20 |
| DERMATHERAPY, MODEL 22216 (K061242) | Precision Fabrics Group, Inc. | 2007-01-25 |
| Z-NET (K001003) | Demite Limited | 2001-12-10 |
| INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW (K940327) | W. L. Gore & Associates, Inc. | 1994-02-25 |
| CORE PREVENT MATTRESS MODIFICATION (K935220) | Paladin Medical, Inc. | 1993-11-29 |
| REUSABLE INCONTIENT UNDERPAD (K924807) | Perfect Fit Industries, Inc. | 1993-02-10 |
| WIPEABLE PILLOW (K924477) | Perfect Fit Industries, Inc. | 1993-01-29 |
| OBALON COVER (K923173) | Turnsoft, Inc. | 1992-11-06 |
| SOFT-COVER (K921928) | Adroit Medical Systems, Inc. | 1992-11-06 |
| ALLERGY CONTROL COVERS (K903382) | Allergy Control Products, Inc. | 1990-11-02 |
| DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST (K902446) | Mallinckrodt Group, Inc. | 1990-08-10 |
| MATTRESS COVER, ANTI-MICROBIAL (K832483) | American Threshold Industries, Inc. | 1984-02-04 |
Recalls involving this device
No recalls on record reference this clearance.