The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Conduit Tcp Granules.
Device ID | K014053 |
510k Number | K014053 |
Device Name: | CONDUIT TCP GRANULES |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Contact | Karen F Jurczak |
Correspondent | Karen F Jurczak DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Product Code | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-12-10 |
Decision Date | 2002-03-08 |
Summary: | summary |