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Gunze Limited
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K221487
NEOVEIL Staple Line Reinforcement
August 26, 2022
K213498
PELNAC Meshed Bilayer Wound Matrix
July 14, 2022
K213573
PELNAC Wound Matrix
February 9, 2022
K191992
PELNAC Bilayer Wound Matrix
April 29, 2020
K130997
NEOVEIL
November 15, 2013