The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Cabot Medical Niagara(tm) 3.0 Liter High Flow Irri.
| Device ID | K924530 |
| 510k Number | K924530 |
| Device Name: | CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Contact | Todd J Polk |
| Correspondent | Todd J Polk CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-08 |
| Decision Date | 1993-02-05 |