FDA 510(k) Applications Submitted by SHIRO AGEHAMA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K230408 |
02/15/2023 |
K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) |
SB-Kawasumi Laboratories, Inc. |
| K190621 |
03/11/2019 |
SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long |
Sumitomo Bakelite Co., Ltd |
| K220799 |
03/18/2022 |
K-SHIELD Zen |
SB-Kawasumi Laboratories, Inc. |
| K182520 |
09/13/2018 |
Flexible Overtube |
Sumitomo Bakelite Co., Ltd |
| K152771 |
09/25/2015 |
SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long |
SUMITOMO BAKELITE CO., LTD. |
| K173004 |
09/27/2017 |
SB Soft Hood - Straight type, SB Soft Hood - Undercut type |
Sumitomo Bakelite Co., Ltd |
| K223810 |
12/20/2022 |
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) |
SB-Kawasumi Laboratories, Inc. |
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