PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75
FDA 510(k) clearance K000915 · decided 2000-05-12
Clearance details
- K-number
- K000915
- Device name
- PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75
- Applicant
- Humagen Fertility Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-03-22
- Decision date
- 2000-05-12
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- MQK
- Device class
- 2
- Regulation number
- 884.6160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Charlottesville, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5. recall (Z-1946-2014) | ORIGIO, Inc | 2014-06-30 |
| IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 ny recall (Z-1220-2007) | Humagen Fertility Diagnostics, Inc. | 2007-09-18 |