The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Norian Srs Fast Set Putty.
Device ID | K060406 |
510k Number | K060406 |
Device Name: | NORIAN SRS FAST SET PUTTY |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
Contact | Angela J Silvestri |
Correspondent | Angela J Silvestri SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
Product Code | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-16 |
Decision Date | 2006-03-20 |
Summary: | summary |