The following data is part of a premarket notification filed by Heraeus Medical Gmbh with the FDA for Palacos R Pro, Palacos R+g Pro, Palacos Mv+g Pro.
Device ID | K210607 |
510k Number | K210607 |
Device Name: | PALACOS R Pro, PALACOS R+G Pro, PALACOS MV+G Pro |
Classification | Bone Cement |
Applicant | Heraeus Medical GmbH Phillipp-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 |
Subsequent Product Code | MBB |
CFR Regulation Number | 888.3027 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2021-03-01 |
Decision Date | 2021-07-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04260102136281 | K210607 | 000 |
04260102136250 | K210607 | 000 |
04260102136229 | K210607 | 000 |
04260102136199 | K210607 | 000 |
04260102136168 | K210607 | 000 |
04260102136120 | K210607 | 000 |