The following data is part of a premarket notification filed by Doctor's Research Group, Inc. with the FDA for Drg Quickmix.
| Device ID | K011736 |
| 510k Number | K011736 |
| Device Name: | DRG QUICKMIX |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | DOCTOR'S RESEARCH GROUP, INC. 143 WOLCOTT RD. Wolcott, CT 06716 |
| Contact | Richard Deslauries |
| Correspondent | Richard Deslauries DOCTOR'S RESEARCH GROUP, INC. 143 WOLCOTT RD. Wolcott, CT 06716 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-05 |
| Decision Date | 2002-01-30 |
| Summary: | summary |