LAURIMED POLYPVAC MICRODEBRIDER
FDA 510(k) clearance K133133 · decided 2013-12-23
Clearance details
- K-number
- K133133
- Device name
- LAURIMED POLYPVAC MICRODEBRIDER
- Applicant
- Laurimed, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-09-30
- Decision date
- 2013-12-23
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- ERL
- Device class
- 2
- Regulation number
- 874.4250
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- San Ramon, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Style recall (Z-1527-2014) | Laurimed LLC | 2014-04-30 |