The following data is part of a premarket notification filed by Portex Ltd. with the FDA for Wallace Dual Lumen Oocyte Retrieval Sets.
| Device ID | K031622 |
| 510k Number | K031622 |
| Device Name: | WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS |
| Classification | Needle, Assisted Reproduction |
| Applicant | PORTEX LTD. MILITARY ROAD HYTHE, KENT England Ct21 6db, GB |
| Contact | Steve Ogilvie |
| Correspondent | Steve Ogilvie PORTEX LTD. MILITARY ROAD HYTHE, KENT England Ct21 6db, GB |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-23 |
| Decision Date | 2003-06-26 |
| Summary: | summary |