510(k) K780779
- Device
- ECONO-FLOAT WATER FLOTATION MATTRESS
- Applicant
- JEFFERSON INDUSTRIES, INC.
- 510(k) number
- K780779
- Product code
- IKY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-05-19
- Date received
- 1978-05-11
- Regulation
- 880.5150
- Classification name
- Mattress, Flotation Therapy, Non-powered
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3013545943
- 3005179379
- 3032847786
- 3013254491
- 3013564718
- 3004116007
- 3002798200
- 3007734888
- 1831750
- 3010394125
- 3010579827
- 3033506545
- 3014165708
- 1043615
- 3009683397
- 1218386
- 3009525805
- 2529695
- 3005484027
- 3004082002
- 3007029061
- 3015423385
- 3012316249
- 3011776382
- 3012363901
- 9616471
- 2032121
- 3007008421
- 1530883
- 1417592
- 3034728569
- 3015286905
- 3016510644
- 1824206
- 3007220726
- 3018117722
- 3004475699
- 1419181
- 3018101346
- 3003542872
- 1531186
- 3029923680
- 2435947
- 3009056001
- 3008791328
- 3009327812
- 3018101395
- 3003641560
- 3006554931
- 3033790380
- 2428983
- 3014256531
- 3017486514
- 3044519507
- 3012643605
- 1041130
- 3006365764
- 1034116
- 8043965
- 1836161
- 3007378235
- 3010526655
- 3042129334
- 2030732
- 3032252823
- 3043460907
- 3006803543
- 3007842980
- 3007420694
- 1832066
- 3009068676
- 3042970964
- 2032476
- 1644196
- 3012392312
- 3014680784
- 9615019
- 3031754383
- 3010515377
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IKY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914921 | SCM-3 AND ACCESSORIES | Gaymar Industries, Inc. | 1992-03-12 |
| K813226 | GEL FLOTATION MATTRESS | Jefferson Industries, Inc. | 1981-12-02 |
| K802781 | BEDDING PADS EGGCREATE PADS | Leemart Bedding Mfg. Co. | 1980-12-10 |
| K802833 | TETRA NATAL-MAT WATER FLOTATION MAT. | Tetra Group U.S.A., Inc. | 1980-12-10 |
| K772062 | NEONATAL FLOTATION SYSTEM | Medpro, Inc. | 1977-11-15 |
| K771824 | MEDPRO FLOTATION SYSTEM | Medpro, Inc. | 1977-10-19 |
| K760963 | DECUBITUS MATTRESS | Arco Medical Products Co. | 1976-11-18 |
Legacy Summary#
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FDA Review#
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