FDA Product Code
FDA Product Code FMW — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6190
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K152884 | DermaTherapy Bed Linens | Precision Fabrics Group, Inc. | 2016-06-20 | Traditional | PDF ↗ |
| K061242 | DERMATHERAPY, MODEL 22216 | Precision Fabrics Group, Inc. | 2007-01-25 | Traditional | PDF ↗ |
| K001003 | Z-NET | Demite Limited | 2001-12-10 | Traditional | PDF ↗ |
| K992702 | EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM | Allergy Direct | 1999-11-08 | Traditional | PDF ↗ |
| K940327 | INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW | W. L. Gore & Associates, Inc. | 1994-02-25 | Traditional | PDF ↗ |
| K935220 | CORE PREVENT MATTRESS MODIFICATION | Paladin Medical, Inc. | 1993-11-29 | Traditional | PDF ↗ |
| K924807 | REUSABLE INCONTIENT UNDERPAD | Perfect Fit Industries, Inc. | 1993-02-10 | Traditional | PDF ↗ |
| K924477 | WIPEABLE PILLOW | Perfect Fit Industries, Inc. | 1993-01-29 | Traditional | PDF ↗ |
| K923173 | OBALON COVER | Turnsoft, Inc. | 1992-11-06 | Traditional | PDF ↗ |
| K921928 | SOFT-COVER | Adroit Medical Systems, Inc. | 1992-11-06 | Traditional | PDF ↗ |
| K903382 | ALLERGY CONTROL COVERS | Allergy Control Products, Inc. | 1990-11-02 | Traditional | PDF ↗ |
| K902446 | DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST | Mallinckrodt Group, Inc. | 1990-08-10 | Traditional | PDF ↗ |
| K832483 | MATTRESS COVER, ANTI-MICROBIAL | American Threshold Industries, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K780033 | MATTRESSES, CONDUCTIVE & COVERS | Chase Mfg. Co. | 1978-02-21 | Traditional | PDF ↗ |
Product code FMW · Class I · General Hospital. Data: openFDA.