The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Marlow Suction/irrigation Probes.
| Device ID | K914872 |
| 510k Number | K914872 |
| Device Name: | MARLOW SUCTION/IRRIGATION PROBES |
| Classification | Antiserum, Fluorescent, Francisella Tularensis |
| 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 | GSJ |
| CFR Regulation Number | 866.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-29 |
| Decision Date | 1991-11-19 |