FDA 510(k) Applications for Medical Device Product Code "LHC"
(Warmer, Irrigation Solution)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K051819 | C CHANGE SURGICAL LLC | C CHANGE SOLUTION WARMER | 08/15/2005 |
| K083417 | C CHANGE SURGICAL LLC | INTRATEMP SOLUTION WARMER | 01/13/2009 |
| K150190 | Ecolab Inc. | IntraTemp Solution Warmer | 02/26/2015 |
| K142080 | ECOLAB, INC. | NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED | 08/28/2014 |
| K142173 | ECOLAB, INC. | NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE | 12/30/2014 |
| K152522 | ECOLAB, INC. | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes | 01/15/2016 |
| K153713 | GETINGE SOURCING, LLC | Getinge Series Warming Cabinet | 06/07/2016 |
| K002859 | KMI KOLSTER METHODS, INC. | SSW-STERILE SOLUTION WARMER | 11/16/2000 |
| K080609 | MAC MEDICAL | SWC/DWC WARMING CABINETS | 06/13/2008 |
| K023283 | O.R. SOLUTIONS, INC. | 1075LD HUSH-SLUSH | 11/13/2002 |
| K021288 | O.R. SOLUTIONS, INC. | ORS-1000LD | 06/27/2002 |
| K023282 | O.R. SOLUTIONS, INC. | ORS-3000LD | 11/13/2002 |
| K021289 | O.R. SOLUTIONS, INC. | WARMER 2000LD | 06/26/2002 |
| K971117 | OLYMPIC MEDICAL CORP. | WARMETTE | 08/22/1997 |
| K965136 | PRINCETON REGULATORY ASSOC. | UROSURGE UROTHERM FLUID WARMING SYSTEM | 10/16/1998 |
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