The following data is part of a premarket notification filed by Sumitomo Bakelite Co., Ltd with the FDA for Sb Knife/short Type, Sb Knife/standard Type, Sb Knife/jr Type, Sb Knife/jr Type - Long.
| Device ID | K190621 |
| 510k Number | K190621 |
| Device Name: | SB Knife/Short Type, SB Knife/Standard Type, SB Knife/Jr Type, SB Knife/Jr Type - Long |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | Sumitomo Bakelite Co., Ltd 5-8, Higashi-Shinagawa 2-chome Shinagawa-ku, JP 1400002 |
| Contact | Shiro Agehama |
| Correspondent | Izumi Maruo MIC International Corp. 4-1-17 Hongo Bunkyo-ku, JP 1130033 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-11 |
| Decision Date | 2019-04-23 |
| Summary: | summary |