The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Bradley Tenaculum Holder.
| Device ID | K903649 |
| 510k Number | K903649 |
| Device Name: | BRADLEY TENACULUM HOLDER |
| Classification | Instrument, Surgical, Disposable |
| 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 | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-13 |
| Decision Date | 1990-11-02 |