The following data is part of a premarket notification filed by Gynetics Medical Products Nv with the FDA for Fas Set #4551.
| Device ID | K013497 |
| 510k Number | K013497 |
| Device Name: | FAS SET #4551 |
| Classification | Needle, 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 | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-22 |
| Decision Date | 2001-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 25425017505840 | K013497 | 000 |
| 25425017503228 | K013497 | 000 |
| 25425017503044 | K013497 | 000 |