The following data is part of a premarket notification filed by Doctors Research Group, Inc. with the FDA for Kryptonite Bone Cement.
Device ID | K091382 |
510k Number | K091382 |
Device Name: | KRYPTONITE BONE CEMENT |
Classification | Methyl Methacrylate For Cranioplasty |
Applicant | DOCTORS RESEARCH GROUP, INC. 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
Contact | Justin Eggleton |
Correspondent | Justin Eggleton DOCTORS RESEARCH GROUP, INC. 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
Product Code | GXP |
CFR Regulation Number | 882.5300 [🔎] |
Decision | Se - With Limitations (SESU) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-05-11 |
Decision Date | 2009-11-16 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
KRYPTONITE BONE CEMENT 76479155 3107197 Dead/Cancelled |
Doctors Research Group 2002-12-26 |