The following data is part of a premarket notification filed by Bsl Co. with the FDA for Automatic Tissue Processing Unit.
Device ID | K172717 |
510k Number | K172717 |
Device Name: | Automatic Tissue Processing Unit |
Classification | System, Suction, Lipoplasty |
Applicant | BSL Co. 6-13, Chilsan-ro 237 Beon-gil Gimhae-si, KR 51006 |
Contact | Jun Suk Lee |
Correspondent | Peter Chung Plus Global 300 Atwood Pittsburgh, PA 15213 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-08 |
Decision Date | 2018-05-25 |
Summary: | summary |