Class Class II

AAMI Level 4 Protective; Gown (K242689)

K242689 2025-01-13 Traditional
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Description

AAMI Level 4 Protective; Gown by Azac Group, an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242689
Clearance Date2025-01-13
Clearance TypeTraditional
Product CodeQPC
Regulation Number878.4040

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