The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Cabot Medical Niagra-trs Thermal Retention System.
| Device ID | K940171 |
| 510k Number | K940171 |
| Device Name: | CABOT MEDICAL NIAGRA-TRS THERMAL RETENTION SYSTEM |
| Classification | System, Thermal Regulating |
| 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 | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-11 |
| Decision Date | 1994-03-09 |