The following data is part of a premarket notification filed by Heraeus Medical Gmbh with the FDA for Palacos Mv Pro.
Device ID | K213812 |
510k Number | K213812 |
Device Name: | PALACOS MV Pro |
Classification | Bone Cement |
Applicant | Heraeus Medical GmbH Philipp-Reis-Str. 8/13 Wehrheim, DE 61273 |
Contact | Ljuba Jaeckel |
Correspondent | Ljuba Jaeckel Heraeus Medical GmbH Philipp-Reis-Str. 8/13 Wehrheim, DE 61273 |
Product Code | LOD |
Subsequent Product Code | JDZ |
Subsequent Product Code | KIH |
CFR Regulation Number | 888.3027 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-12-07 |
Decision Date | 2022-02-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04260102135376 | K213812 | 000 |
04260102135338 | K213812 | 000 |