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 |