The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Malleable Stylet 18 Cm Me1816st, 23 Cm Me1816nst.
| Device ID | K962273 |
| 510k Number | K962273 |
| Device Name: | MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST |
| Classification | Cannula, Intrauterine Insemination |
| Applicant | MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Contact | Arthur S Goddard |
| Correspondent | Arthur S Goddard 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 | 1996-06-13 |
| Decision Date | 1996-07-31 |