The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Fast Set Putty.
Device ID | K012589 |
510k Number | K012589 |
Device Name: | FAST SET PUTTY |
Classification | Methyl Methacrylate For Cranioplasty |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Thomas M Maguire |
Correspondent | Thomas M Maguire SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Product Code | GXP |
CFR Regulation Number | 882.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-08-10 |
Decision Date | 2002-02-07 |
Summary: | summary |