The following data is part of a premarket notification filed by Gynetics Medical Products Nv with the FDA for Emtrac; Delphin; Semtrac 2000 Set.
| Device ID | K013536 |
| 510k Number | K013536 |
| Device Name: | EMTRAC; DELPHIN; SEMTRAC 2000 SET |
| Classification | Catheter, Assisted Reproduction |
| Applicant | GYNETICS MEDICAL PRODUCTS NV 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland GYNETICS MEDICAL PRODUCTS NV 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-23 |
| Decision Date | 2001-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 25425017501026 | K013536 | 000 |
| 25425017501415 | K013536 | 000 |
| 25425017501316 | K013536 | 000 |
| 25425017501118 | K013536 | 000 |
| 25425017501101 | K013536 | 000 |
| 25425017501088 | K013536 | 000 |
| 25425017501071 | K013536 | 000 |
| 05425017501053 | K013536 | 000 |
| 05425017501022 | K013536 | 000 |