The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Nezhat Irrigation Pump System.
| Device ID | K880763 |
| 510k Number | K880763 |
| Device Name: | NEZHAT IRRIGATION PUMP SYSTEM |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Contact | Todd Polk |
| Correspondent | Todd 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 | 1988-02-25 |
| Decision Date | 1988-05-24 |