The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette.
| Device ID | K151018 |
| 510k Number | K151018 |
| Device Name: | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette |
| Classification | Microtools, Assisted Reproduction (pipettes) |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Naomi Funkhouser |
| Correspondent | Naomi Funkhouser COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | MQH |
| CFR Regulation Number | 884.6130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-16 |
| Decision Date | 2016-01-08 |
| Summary: | summary |