The following data is part of a premarket notification filed by Washington Regulatory Services with the FDA for Intra-uterine Transfer, Intra-folopian Transfer.
| Device ID | K983604 |
| 510k Number | K983604 |
| Device Name: | INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER |
| Classification | Catheter, Assisted Reproduction |
| Applicant | WASHINGTON REGULATORY SERVICES 23 WELISEWITZ RD. Ringoes, NJ 08551 |
| Contact | Randolph L Cooke |
| Correspondent | Randolph L Cooke WASHINGTON REGULATORY SERVICES 23 WELISEWITZ RD. Ringoes, NJ 08551 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-14 |
| Decision Date | 1999-05-27 |
| Summary: | summary |