The following data is part of a premarket notification filed by Carefusion with the FDA for Avamax Vertebral Balloon.
Device ID | K103064 |
510k Number | K103064 |
Device Name: | AVAMAX VERTEBRAL BALLOON |
Classification | Cement, Bone, Vertebroplasty |
Applicant | CAREFUSION 1500 WAUKEGAN ROAD Waukegan, IL 60085 |
Contact | Joy Greidanus |
Correspondent | Joy Greidanus CAREFUSION 1500 WAUKEGAN ROAD Waukegan, IL 60085 |
Product Code | NDN |
CFR Regulation Number | 888.3027 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-10-18 |
Decision Date | 2011-01-10 |
Summary: | summary |