510(k) K001003
- Device
- Z-NET
- Applicant
- DEMITE LIMITED
- 510(k) number
- K001003
- Product code
- FMW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-12-10
- Date received
- 2000-03-29
- Regulation
- 880.6190
- Classification name
- Cover, Mattress (medical Purposes)
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM H.E. VON OEHSEN
- Address
- 1001 Pennsylvania Ave. Nw. 6th Floor Washington DC US 20004 20004
FDA Registration Numbers#
- 3005179379
- 3009149661
- 3015526463
- 3017408377
- 3029983606
- 3032847103
- 3010373530
- 3045058049
- 3005652389
- 3010373263
- 3002798200
- 3006537699
- 3010920695
- 3015068387
- 1039577
- 3009979773
- 3011497662
- 3016590299
- 3010595915
- 9681786
- 3033883981
- 1831750
- 3015219076
- 3018778939
- 3033506545
- 9611959
- 3008466086
- 1218386
- 3016712306
- 3017607477
- 3008212609
- 3023339277
- 3042276341
- 2133465
- 3015058854
- 3010890274
- 1933975
- 3038623066
- 3038718579
- 3010359088
- 3003890648
- 3004082002
- 3014928153
- 1066748
- 3015337373
- 3015423385
- 3012316249
- 3006786326
- 3027847726
- 3017375560
- 3001644167
- 3013298431
- 3010580775
- 3012363901
- 3033511100
- 2032121
- 3017953189
- 3007008421
- 3012775375
- 3016712364
- 3034728569
- 3016457665
- 3007608369
- 3039282838
- 3007220726
- 1523547
- 3004475699
- 3031980467
- 3023323193
- 1531186
- 3003855936
- 3008970204
- 3008058406
- 3038285060
- 3002637602
- 3024787345
- 3017171460
- 3032596656
- 3014739961
Source Documents#
Other 510(k) Records For Product Code FMW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152884 | DermaTherapy Bed Linens | Precision Fabrics Group, Inc. | 2016-06-20 |
| K061242 | DERMATHERAPY, MODEL 22216 | Precision Fabrics Group, Inc. | 2007-01-25 |
| K992702 | EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM | Allergy Direct | 1999-11-08 |
| K940327 | INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW | W. L. Gore & Associates, Inc. | 1994-02-25 |
| K935220 | CORE PREVENT MATTRESS MODIFICATION | Paladin Medical, Inc. | 1993-11-29 |
| K924807 | REUSABLE INCONTIENT UNDERPAD | Perfect Fit Industries, Inc. | 1993-02-10 |
| K924477 | WIPEABLE PILLOW | Perfect Fit Industries, Inc. | 1993-01-29 |
| K921928 | SOFT-COVER | Adroit Medical Systems, Inc. | 1992-11-06 |
| K923173 | OBALON COVER | Turnsoft, Inc. | 1992-11-06 |
| K903382 | ALLERGY CONTROL COVERS | Allergy Control Products, Inc. | 1990-11-02 |
| K902446 | DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST | Mallinckrodt Group, Inc. | 1990-08-10 |
| K832483 | MATTRESS COVER, ANTI-MICROBIAL | American Threshold Industries, Inc. | 1984-02-04 |
| K780033 | MATTRESSES, CONDUCTIVE & COVERS | Chase Mfg. Co. | 1978-02-21 |
Legacy Summary#
summary
FDA Review#
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