The following data is part of a premarket notification filed by Laurimed Llc with the FDA for Polypvac Microdebrider (3.3mm And 4.0mm).
| Device ID | K161101 |
| 510k Number | K161101 |
| Device Name: | PolypVac Microdebrider (3.3mm And 4.0mm) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-19 |
| Decision Date | 2016-06-22 |
| Summary: | summary |