The following data is part of a premarket notification filed by Fertility Technology Resources, Inc. with the FDA for Mona Lisa Aspiration Needle.
| Device ID | K032208 |
| 510k Number | K032208 |
| Device Name: | MONA LISA ASPIRATION NEEDLE |
| Classification | Needle, Assisted Reproduction |
| Applicant | FERTILITY TECHNOLOGY RESOURCES, INC. 4343 SHALLOWFORD RD. SUITE D-4 Marietta, GA 30062 |
| Contact | Constance W Sturgeon |
| Correspondent | Constance W Sturgeon FERTILITY TECHNOLOGY RESOURCES, INC. 4343 SHALLOWFORD RD. SUITE D-4 Marietta, GA 30062 |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-18 |
| Decision Date | 2003-12-09 |