The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Edwards-wallace Bourne Hall Catheter.
| Device ID | K910577 |
| 510k Number | K910577 |
| Device Name: | EDWARDS-WALLACE BOURNE HALL CATHETER |
| Classification | Cannula, Intrauterine Insemination |
| Applicant | MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Contact | Scott C Marlow |
| Correspondent | Scott C Marlow MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Product Code | MFD |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-11 |
| Decision Date | 1991-05-09 |