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 |