The following data is part of a premarket notification filed by Doctor's Research Group, Inc. with the FDA for Drg Laryngeal Augmentation Implant Device.
| Device ID | K051487 |
| 510k Number | K051487 |
| Device Name: | DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | DOCTOR'S RESEARCH GROUP, INC. 50 ALTAIR AVE. Plymouth, CT 06782 |
| Contact | Mahmud Ahmed |
| Correspondent | Mahmud Ahmed DOCTOR'S RESEARCH GROUP, INC. 50 ALTAIR AVE. Plymouth, CT 06782 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-06 |
| Decision Date | 2005-12-22 |
| Summary: | summary |