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FDA 510(k) Applications Submitted by Gunze Limited
FDA 510(k) Number
Submission Date
Device Name
Applicant
K221487
05/23/2022
NEOVEIL Staple Line Reinforcement
Gunze Limited
K191992
07/25/2019
PELNAC Bilayer Wound Matrix
Gunze Limited
K213498
11/01/2021
PELNAC Meshed Bilayer Wound Matrix
Gunze Limited
K213573
11/10/2021
PELNAC Wound Matrix
Gunze Limited
K130997
04/10/2013
NEOVEIL
GUNZE LIMITED
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