The following data is part of a premarket notification filed by Laurimed Llc with the FDA for 3.3 Mm Laurimed Microdebrider; 4.0 Mm Laurimed Microdebrider.
| Device ID | K163247 |
| 510k Number | K163247 |
| Device Name: | 3.3 Mm Laurimed Microdebrider; 4.0 Mm Laurimed Microdebrider |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | LAURIMED LLC 500 ARGUELLO ST., SUITE 100 Redwood City, CA 94063 |
| Contact | Brian R Dubois |
| Correspondent | Brian R Dubois LAURIMED LLC 500 ARGUELLO ST., SUITE 100 Redwood City, CA 94063 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-18 |
| Decision Date | 2017-03-09 |
| Summary: | summary |