The following data is part of a premarket notification filed by Heraeus Medical Gmbh with the FDA for Palacos R Pro.
Device ID | K150119 |
510k Number | K150119 |
Device Name: | PALACOS R Pro |
Classification | Bone Cement |
Applicant | HERAEUS MEDICAL GMBH PHILIPP-REIS-STR. 8-13 Wehrheim, DE 61273 |
Contact | Astrid Marx |
Correspondent | Tina Wu-murphy ICON Plc 62 Forest Street Suite 300 Marlborough, MA 01752 |
Product Code | LOD |
Subsequent Product Code | JDZ |
Subsequent Product Code | KIH |
CFR Regulation Number | 888.3027 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-01-20 |
Decision Date | 2015-06-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04260102135970 | K150119 | 000 |