The following data is part of a premarket notification filed by Getinge Sourcing, Llc with the FDA for Getinge Series Warming Cabinet.
| Device ID | K153713 |
| 510k Number | K153713 |
| Device Name: | Getinge Series Warming Cabinet |
| Classification | Warmer, Irrigation Solution |
| Applicant | GETINGE SOURCING, LLC 1777 EAST HENRIETTA ROAD Rochester, NY 14623 |
| Contact | Barb Smith |
| Correspondent | Barb Smith GETINGE SOURCING, LLC 1777 EAST HENRIETTA ROAD Rochester, NY 14623 |
| Product Code | LHC |
| CFR Regulation Number | 890.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-24 |
| Decision Date | 2016-06-07 |
| Summary: | summary |