The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Intracytoplasmic Sperm Injection (icsi) Micro-injection Pipettes, Holding Pipettes, Denuding Pipettes, Assisted Hatching.
Device ID | K983596 |
510k Number | K983596 |
Device Name: | INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING |
Classification | Microtools, Assisted Reproduction (pipettes) |
Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
Contact | Debbie Schmitt |
Correspondent | Debbie Schmitt COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
Product Code | MQH |
CFR Regulation Number | 884.6130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-13 |
Decision Date | 1999-02-05 |
Summary: | summary |