510(k) K022387
- Device
- CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC
- Applicant
- CRAFTMATIC ORGANIZATION, INC.
- 510(k) number
- K022387
- Product code
- LLI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-09-19
- Date received
- 2002-07-23
- Regulation
- 880.5100
- Classification name
- Bed, Therapeutic, Ac-powered, Adjustable Home-use
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL D RUBIN
- Address
- 2550 M St. NW Washington DC US 20037 20037
FDA Registration Numbers#
- 3008058231
- 3008386649
- 9616091
- 3011719874
- 3034731542
- 2183191
- 3015979371
- 3017580820
- 3007689746
- 3008061384
- 3003751839
- 3009327812
- 3008830652
- 3003749961
- 3039527731
- 3014615038
- 3015337241
- 3008951110
- 1644196
- 3010880685
- 3030488262
- 3017171467
- 1531186
- 1417592
- 3033849261
- 3038277448
- 3008466086
- 3009265647
- 1430016
- 3030019986
- 3006891315
- 3034629632
- 3015969549
- 3012392312
- 3038304894
- 3014563360
- 3006795832
- 3030452839
- 3003908754
- 3027614450
- 3008533516
Source Documents#
Other 510(k) Records For Product Code LLI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K840787 | CRAFTMATIC ELECTRIC ADJUSTABLE BED | Contour, Inc. | 1984-06-13 |
Legacy Summary#
summary
FDA Review#
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