The following data is part of a premarket notification filed by Laurimed Llc with the FDA for Laurimed Polypvac Microdebrider.
| Device ID | K133133 |
| 510k Number | K133133 |
| Device Name: | LAURIMED POLYPVAC MICRODEBRIDER |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | LAURIMED LLC 8 CROW CANYON COURT, STE 205 San Ramon, CA 94583 |
| Contact | Nancy Lince, Rac |
| Correspondent | Nancy Lince, Rac LAURIMED LLC 8 CROW CANYON COURT, STE 205 San Ramon, CA 94583 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2013-12-23 |
| Summary: | summary |