The following data is part of a premarket notification filed by Bm Korea Co., Ltd. with the FDA for Guardian-sg Inflatable Bone Expander System.
| Device ID | K143006 |
| 510k Number | K143006 |
| Device Name: | GUARDIAN-SG Inflatable Bone Expander System |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | BM KOREA CO., LTD. 325-26 DANGJEONG-DONG Gunpo-si, KR 435-832 |
| Contact | June Han |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92833 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-20 |
| Decision Date | 2015-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809255544633 | K143006 | 000 |
| 08809255540987 | K143006 | 000 |