The following data is part of a premarket notification filed by Ecolab, Inc. with the FDA for Non-sterile Ors Warning Drapes/slush+warmer Disc-drape/slush+warmer Palte-drape /fluid Warmer Drape,skirted.
| Device ID | K142080 |
| 510k Number | K142080 |
| Device Name: | NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED |
| Classification | Warmer, Irrigation Solution |
| Applicant | ECOLAB, INC. 370 WABASHA STREET NORTH St.paul, MN 55102 |
| Contact | Jennifer Willner |
| Correspondent | Jennifer Willner ECOLAB, INC. 370 WABASHA STREET NORTH St.paul, MN 55102 |
| Product Code | LHC |
| CFR Regulation Number | 890.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-31 |
| Decision Date | 2014-08-28 |
| Summary: | summary |