The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Cabot Medical Irrigation Fluid Warmer Sets.
| Device ID | K932538 |
| 510k Number | K932538 |
| Device Name: | CABOT MEDICAL IRRIGATION FLUID WARMER SETS |
| Classification | Warmer, Irrigation Solution |
| 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 | LHC |
| CFR Regulation Number | 890.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-26 |
| Decision Date | 1994-02-22 |