The following data is part of a premarket notification filed by Hertart Aps with the FDA for Pasteur Pipette 3ml, Pasteur Pipette 1ml.
| Device ID | K201213 |
| 510k Number | K201213 |
| Device Name: | Pasteur Pipette 3mL, Pasteur Pipette 1mL |
| Classification | Labware, Assisted Reproduction |
| Applicant | HertART Aps Gustaf Werners Gata 2 Vastra Frolunda, SE Se-421 32 |
| Contact | Per Svensson |
| Correspondent | Ann-catherine Ericson HertART Aps Gustaf Werners Gata 2 Vastra Frolunda, SE Se-421 32 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-05 |
| Decision Date | 2020-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350025914623 | K201213 | 000 |
| 17350025914616 | K201213 | 000 |