SOFTXIL
Elastomer, Silicone Block
BISTOOL
The following data is part of a premarket notification filed by Bistool with the FDA for Softxil.
Pre-market Notification Details
| Device ID | K171851 |
| 510k Number | K171851 |
| Device Name: | SOFTXIL |
| Classification | Elastomer, Silicone Block |
| Applicant | BISTOOL 9, Gwangnaru-ro 6-gil Seongdong-gu Seoul, KR 04796 |
| Contact | Eunhyun Bae |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine, CA 92620 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-21 |
| Decision Date | 2018-03-16 |
| Summary: | summary |
Trademark Results [SOFTXIL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOFTXIL 88570413 not registered Live/Pending |
BAE, Eun Hyun 2019-08-07 |
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