The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Cabot Medical Niagara Fluid Management Pump.
| Device ID | K941743 |
| 510k Number | K941743 |
| Device Name: | CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP |
| Classification | Insufflator, Hysteroscopic |
| 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 | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-07 |
| Decision Date | 1995-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925000322 | K941743 | 000 |