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FDA 510(k) Applications for Medical Device Product Code "OUK"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K101128
FILLIGENT LIMITED
BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
05/26/2011
K192105
Innonix Technologies Limited
Innonix Antiviral Child's Face Mask
11/29/2019
K182766
NBC Meshtec Inc.
Cufitec Surgical Mask
01/03/2019
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