Atlas FDA

MNE

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Orthosis, Moldable, Supportive, Skin Protective
Device class
Class I (low risk)
Regulation
21 CFR 890.3475
Medical specialty
Physical Medicine
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RecordFirmDate
PODIATRIC MATERIAL (K940132)Crown Delta Corp.1994-09-29
PODIATRIC MATERIAL (K780391)Crown Delta Corp.1978-06-14

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Every clearance here is in the API, with alerts when new ones post.