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Gri-Alleset, Inc.

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories3
Latest Approval2024-11-05
TypeNumberDevice NameCodeDate
510(k) K242664 gentleheel® Adult Incision Device FMK 2024-11-05 View
510(k) K220917 gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler FMK 2022-05-18 View
510(k) K210860 Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 FXX 2022-04-07 View
510(k) K210131 ComfortGuard Surgical Isolation Gown FYC 2021-08-26 View
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