The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Ovum Pick-up Needles With Aq Coating, Aspiration Needles With Aq Coating.
| Device ID | K994417 |
| 510k Number | K994417 |
| Device Name: | OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING |
| Classification | Needle, Assisted Reproduction |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Debbie Schmitt |
| Correspondent | Debbie Schmitt COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-29 |
| Decision Date | 2000-03-01 |
| Summary: | summary |