Medical Device Manufacturer · JP , Shimada-City

San-M Package Co., Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2016
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - San-M Package Co., Ltd. General Hospital ✕
3 devices
1-3 of 3
Cleared Sep 16, 2022
Surgical Face Masks (Ear Loops And Tie-On)
K221534 · FXX
General Hospital · 112d
Cleared Sep 06, 2016
Surgical Face Masks (Ear loops and Tie-on)
K160269 · FXX
General Hospital · 217d
Cleared Jul 15, 2016
N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
K160271 · MSH
General Hospital · 164d
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