510(k) K992702
- Device
- EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
- Applicant
- ALLERGY DIRECT
- 510(k) number
- K992702
- Product code
- FMW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-11-08
- Date received
- 1999-08-12
- 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
- GAVIN MCLACLAN
- Address
- 8800 E. 63rd St. Kansas City MO US 64133 64133
FDA Registration Numbers#
- 3007029063
- 3009327812
- 3017171460
- 3038718579
- 3002637602
- 3010890274
- 3008950965
- 9615245
- 3008058406
- 3009402404
- 1422443
- 3010595915
- 1034116
- 3009278376
- 3019315271
- 1062671
- 3005179379
- 3007307488
- 1065597
- 3010373263
- 3015526491
- 3012709011
- 3013684902
- 3003307279
- 9611326
- 3010580775
- 3038623066
- 3015288041
- 3016816754
- 3012242151
- 3043126908
- 3007798904
- 3014674312
- 3033511100
- 2133465
- 3012344767
- 2428983
- 1528695
- 8030877
- 3016171961
- 3008212609
- 3007134585
- 3011091529
- 1053198
- 3031027
- 3010373530
- 3005033444
- 1066748
- 3017408377
- 3013685983
- 3014666579
- 3014680784
- 3005273623
- 3009149661
- 3023323193
- 3015423385
- 3015068387
- 3010699720
- 3007608369
- 3015219076
- 3009655869
- 3012316249
- 2032476
- 3029983606
- 3011556876
- 3003890648
- 3006537699
- 2031723
- 9616872
- 3012775375
- 3007212927
- 3027847726
- 1649595
- 1836161
- 3037012186
- 3033883981
- 1531186
- 2030732
- 3023265420
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 |
| K001003 | Z-NET | Demite Limited | 2001-12-10 |
| 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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