510(k) K791350
- Device
- POPE AMBULATORY HALO VEST
- Applicant
- HOSPITAL PRODUCTS CO.
- 510(k) number
- K791350
- Product code
- IQF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-08-03
- Date received
- 1979-07-17
- Regulation
- 890.3490
- Classification name
- Orthosis, Cervical-thoracic, Rigid
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2031823
- 1643116
- 3017697442
- 3034669683
- 3014560743
- 3016450032
- 3005841961
- 3009303371
- 2031918
- 3006227741
- 3029702497
- 1063727
- 3014896622
- 3034694939
- 3007123908
- 3017417635
- 1026765
- 3007774549
- 3005885000
- 3039396083
- 3016591678
- 3012330365
- 3006801236
- 3016758972
- 1528759
- 1226318
- 3006755899
- 9617759
- 1018470
- 3005282622
- 3010182295
- 1526439
- 3014943293
- 3008395114
- 3005951403
- 3013524663
- 9616086
- 3016707060
- 3007109661
- 3004067876
- 3005906953
- 1824252
- 1060680
- 3006943846
- 1043214
- 3017421556
- 3011528799
- 3015745029
- 3017264244
- 1000357070
- 3017910381
- 1417592
- 1721652
- 8010822
- 3033436414
- 3031170295
- 3003981946
- 1641302
- 3035551807
- 3007392395
- 3013657868
- 3031606416
- 3031184338
- 3014301546
- 1063312
- 3011786430
- 3042227943
- 3002754225
- 3010830834
- 3009703478
- 3011650322
- 3008808082
- 3012314549
- 3027617478
- 2950684
- 3008273892
- 3022549
- 3016147813
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IQF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K832741 | JASON CERVICAL ORTHOSIS | Orthomedics | 1983-09-20 |
| K812342 | ZEE EXTRICATION DEVICE | Zee Medical Products Co., Inc. | 1981-09-21 |
| K811297 | CERVICAL SUPPORT | Orthomedics | 1981-05-27 |
| K810555 | SCOLIOSIS ORTHOTIC SYSTEM | Orthomedics | 1981-03-13 |
| K781761 | KENDRICK EXTRICATION DEVICE | Medi-Ked, Inc. | 1978-10-27 |
| K780489 | SPINE BOARD | Marullo, Baldwin, Frieden, Gatewood, | 1978-04-12 |
Legacy Summary#
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FDA Review#
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