The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Reich Suction/irrigation Cannula.
| Device ID | K911164 |
| 510k Number | K911164 |
| Device Name: | REICH SUCTION/IRRIGATION CANNULA |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-15 |
| Decision Date | 1991-07-05 |