The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Marlow Verres Needles.
| Device ID | K913586 |
| 510k Number | K913586 |
| Device Name: | MARLOW VERRES NEEDLES |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Contact | Scott Marlow |
| Correspondent | Scott Marlow MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-12 |
| Decision Date | 1991-10-08 |