The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Wallace Artificial Insemination Catheter.
| Device ID | K061679 |
| 510k Number | K061679 |
| Device Name: | WALLACE ARTIFICIAL INSEMINATION CATHETER |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Contact | Wendell Lee |
| Correspondent | Wendell Lee IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-15 |
| Decision Date | 2006-10-13 |
| Summary: | summary |