Pasteur Pipette 3mL, Pasteur Pipette 1mL
FDA 510(k) clearance K201213 · decided 2020-12-16
Clearance details
- K-number
- K201213
- Device name
- Pasteur Pipette 3mL, Pasteur Pipette 1mL
- Applicant
- Hertart Aps
- Decision
- Substantially Equivalent
- Date received
- 2020-05-05
- Decision date
- 2020-12-16
- Days to decision
- 225 days
- Clearance type
- Traditional
- Product code
- MQK
- Device class
- 2
- Regulation number
- 884.6160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Västra Frölunda, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.