The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Altapore.
Device ID | K192363 |
510k Number | K192363 |
Device Name: | Altapore |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 |
Contact | Phillip Romei |
Correspondent | Phillip Romei Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 |
Product Code | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-30 |
Decision Date | 2020-01-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ALTAPORE 87534623 not registered Live/Pending |
Baxter International Inc. 2017-07-19 |
ALTAPORE 87165257 5633374 Live/Registered |
Baxter International Inc. 2016-09-08 |
ALTAPORE 86064462 not registered Dead/Abandoned |
Baxter International Inc. 2013-09-13 |
ALTAPORE 86008035 not registered Dead/Abandoned |
Baxter International Inc. 2013-07-11 |