The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Actifuse Flow.
Device ID | K181306 |
510k Number | K181306 |
Device Name: | Actifuse Flow |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | Baxter Healthcare Corporation 32650 N Wilson Rd Round Lake, IL 60073 |
Contact | Daniel Davis |
Correspondent | Daniel Davis Baxter Healthcare Corporation 32650 N Wilson Rd Round Lake, IL 60073 |
Product Code | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-05-17 |
Decision Date | 2018-08-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
55060050780789 | K181306 | 000 |
55060050780772 | K181306 | 000 |
55060050780765 | K181306 | 000 |