The following data is part of a premarket notification filed by Hans Biomed Corp. with the FDA for Bellafuse.
| Device ID | K151271 |
| 510k Number | K151271 |
| Device Name: | BellaFuse |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Hans Biomed Corp. 64,Yuseong-Daero 1628Beon-Gil, Yuseong-Gu Daejeon, KR 305-811 |
| Contact | Lucy Choi |
| Correspondent | Patsy J Trisler Trisler Consulting 5600 Wisconsin Ave, #509 Chevy Chase, MD 20815 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-13 |
| Decision Date | 2016-03-11 |
| Summary: | summary |