The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Modification To Intracytoplasmic Sperm Injection (isci), Micro-injection Pipettes, Holding Pipettes, Denuding Pipettes,.
| Device ID | K033903 |
| 510k Number | K033903 |
| Device Name: | MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING 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 |