The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Ott Cervical Tenaculum.
| Device ID | K910287 |
| 510k Number | K910287 |
| Device Name: | OTT CERVICAL TENACULUM |
| Classification | Tenaculum, Uterine |
| 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 | HDC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-22 |
| Decision Date | 1991-02-28 |