510(k) K964848 ยท MFD Cannula, Intrauterine Insemination
WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM
| Applicant | Marlow Surgical Technologies, Inc., Willoughby OH, US |
| Decision | Substantially Equivalent, Jan 16, 1997 |
| Received | Dec 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964848
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2020 | CooperSurgical, Inc. Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the i Terminated |
MFD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.