The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Pre-implantation Genetic Diagnosis Pipettes (biopsy Pipettes).
| Device ID | K033904 |
| 510k Number | K033904 |
| Device Name: | PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) |
| Classification | Microtools, Assisted Reproduction (pipettes) |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer, IN 47460 |
| Contact | Brenda Davis |
| Correspondent | Brenda Davis COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer, IN 47460 |
| Product Code | MQH |
| CFR Regulation Number | 884.6130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-17 |
| Decision Date | 2004-01-16 |
| Summary: | summary |