HEMOPORE
FDA 510(k) clearance K141816 · decided 2014-10-23
Clearance details
- K-number
- K141816
- Device name
- HEMOPORE
- Applicant
- Polyganics B.V.,
- Decision
- Substantially Equivalent
- Date received
- 2014-07-07
- Decision date
- 2014-10-23
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- LYA
- Device class
- 1
- Regulation number
- 874.4780
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Groningen, NL
- Third-party review
- No
- Expedited review
- No
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| SPIWay Endonasal Access Guide (K153686) | Spiway, LLC | 2016-01-28 |
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| NASOPORE-FD (K141423) | Polyganics B.V., | 2014-08-07 |
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Recalls involving this device
No recalls on record reference this clearance.