The following data is part of a premarket notification filed by Ecolab, Inc. with the FDA for Ors-3000ld Slush Drapes, Ors-1000ld Fluid Warming Drapes.
| Device ID | K152522 |
| 510k Number | K152522 |
| Device Name: | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes |
| Classification | Warmer, Irrigation Solution |
| Applicant | ECOLAB, INC. 370 WABASHA STREET NORTH Saint Paul, MN 55102 |
| Contact | Jennifer Willner |
| Correspondent | Jennifer Willner ECOLAB, INC. 370 WABASHA STREET NORTH Saint 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 | 2015-09-03 |
| Decision Date | 2016-01-15 |
| Summary: | summary |