The following data is part of a premarket notification filed by Sims Portex Ltd. with the FDA for Wallace Oocyte Retrieval Sets 16g, Wallace Oocyte Retrieval Set 17g, Models Meons 1633s, Meons 1733s.
| Device ID | K012068 |
| 510k Number | K012068 |
| Device Name: | WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S |
| Classification | Needle, Assisted Reproduction |
| Applicant | SIMS PORTEX LTD. HYTHE Hythe, Kent, GB Ct 21 6jl |
| Contact | Claire Mullins |
| Correspondent | Claire Mullins SIMS PORTEX LTD. HYTHE Hythe, Kent, GB Ct 21 6jl |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-02 |
| Decision Date | 2001-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30888937021142 | K012068 | 000 |
| 30888937020961 | K012068 | 000 |
| 30888937020978 | K012068 | 000 |
| 30888937020985 | K012068 | 000 |
| 30888937020992 | K012068 | 000 |
| 30888937021005 | K012068 | 000 |
| 30888937021012 | K012068 | 000 |
| 30888937021029 | K012068 | 000 |
| 30888937021036 | K012068 | 000 |
| 30888937021050 | K012068 | 000 |
| 30888937021067 | K012068 | 000 |
| 30888937021081 | K012068 | 000 |
| 30888937021098 | K012068 | 000 |
| 30888937021111 | K012068 | 000 |
| 30888937021128 | K012068 | 000 |
| 30888937021135 | K012068 | 000 |
| 30888937020954 | K012068 | 000 |