The following data is part of a premarket notification filed by Sims Portex Ltd. with the FDA for Wallace Oocyte Retrieval Set-16g, Model Meons1633; Wallace Oocyte Retrieval Set-17g, Model Meons1733.
| Device ID | K000628 |
| 510k Number | K000628 |
| Device Name: | WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 |
| Classification | Needle, Assisted Reproduction |
| Applicant | SIMS PORTEX LTD. HYTHE Kent, GB Ct21 6jl |
| Contact | Giles Bishop |
| Correspondent | Giles Bishop SIMS PORTEX LTD. HYTHE Kent, GB Ct21 6jl |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-24 |
| Decision Date | 2000-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30888937021104 | K000628 | 000 |
| 30888937021074 | K000628 | 000 |
| 30888937021043 | K000628 | 000 |