The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Irrigation Pump And Tubing Set.
| Device ID | K924611 |
| 510k Number | K924611 |
| Device Name: | IRRIGATION PUMP AND TUBING SET |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Contact | Craig R Lanese |
| Correspondent | Craig R Lanese MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-11 |
| Decision Date | 1994-06-30 |