The following data is part of a premarket notification filed by Heraeus Medical Gmbh with the FDA for Osteopal Plus.
Device ID | K153737 |
510k Number | K153737 |
Device Name: | OSTEOPAL Plus |
Classification | Bone Cement |
Applicant | HERAEUS MEDICAL GMBH PHILIPP-REIS-STR. 8-13 Wehrheim, DE 61273 |
Contact | Astrid Marx |
Correspondent | Gordon Macfarlane ICON Plc 62 Forest Street Marlborough, MA 01752 |
Product Code | LOD |
CFR Regulation Number | 888.3027 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-12-28 |
Decision Date | 2016-04-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04260102132603 | K153737 | 000 |